Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-28 @ 10:17 AM
Study NCT ID:
NCT00922766
Status:
COMPLETED
Last Update Posted:
2012-01-23
First Post:
2009-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017985', 'term': 'Dalteparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Dalteparin', 'description': 'Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.', 'otherNumAtRisk': 617, 'otherNumAffected': 23, 'seriousNumAtRisk': 617, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gingival Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lower Respiratory Tract Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Respiratory Rate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hemiplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pruritus Generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Venous Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cardio-respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Left Ventricular Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Death or Myocardial Infarction (MI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '617', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalteparin', 'description': 'Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 28 days after last dose of study drug', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all enrolled participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Major Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '617', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalteparin', 'description': 'Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 28 days after last dose of study drug', 'description': 'Bleeding events were considered major if, accompanied by a decrease in hemoglobin of more than or equal to 2 grams/deciliter (g/dL) in connection with clinical symptoms; a transfusion was required; bleeding led to interruption of treatment or death; or intracranial bleeding.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all enrolled participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Minor Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '617', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalteparin', 'description': 'Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 28 days after last dose of study drug', 'description': 'Bleeding events like hematuria, wound hematoma or injection site hematoma which did not fulfill the criteria for a major bleeding episode were classified as minor bleeding.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all enrolled participants who received at least 1 dose of the study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '617', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalteparin', 'description': 'Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 28 days after last dose of study drug', 'description': 'Stroke was defined as a sudden, focal neurologic deficit that was not reversible within 24 hours and was not the result of any readily identifiable cause (for example, tumor or trauma).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all enrolled participants who received at least 1 dose of the study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Cardiac Arrest- Resuscitated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '617', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalteparin', 'description': 'Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 28 days after last dose of study drug', 'description': 'Cardiac arrest resuscitated was defined as sudden cessation of cardiac activity so that the participant became unresponsive, with no normal breathing and no signs of circulation. Cardiac arrest was used to signify an event that was reversed, usually by cardio-pulmonary resuscitation (CPR) and/or defibrillation or cardioversion, or cardiac pacing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all enrolled participants who received at least 1 dose of the study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Heparin Induced Thrombocytopenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '617', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalteparin', 'description': 'Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 28 days after last dose of study drug', 'description': 'Thrombocytopenia was defined as a disorder in which there is an abnormally low platelet count. A normal platelet count ranged from 150,000 to 450,000 platelets per micro liter of blood.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all enrolled participants who received at least 1 dose of the study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dalteparin', 'description': 'Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '617'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '610'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': "A total of 618 participants were screened, of which 617 participant were assigned to study treatment and 1 participant was excluded based on investigator's discretion."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '617', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dalteparin', 'description': 'Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'spread': '12.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '249', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '368', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 618}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-19', 'studyFirstSubmitDate': '2009-06-16', 'resultsFirstSubmitDate': '2011-10-07', 'studyFirstSubmitQcDate': '2009-06-16', 'lastUpdatePostDateStruct': {'date': '2012-01-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-07', 'studyFirstPostDateStruct': {'date': '2009-06-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Stroke', 'timeFrame': 'Baseline to 28 days after last dose of study drug', 'description': 'Stroke was defined as a sudden, focal neurologic deficit that was not reversible within 24 hours and was not the result of any readily identifiable cause (for example, tumor or trauma).'}, {'measure': 'Number of Participants With Cardiac Arrest- Resuscitated', 'timeFrame': 'Baseline to 28 days after last dose of study drug', 'description': 'Cardiac arrest resuscitated was defined as sudden cessation of cardiac activity so that the participant became unresponsive, with no normal breathing and no signs of circulation. Cardiac arrest was used to signify an event that was reversed, usually by cardio-pulmonary resuscitation (CPR) and/or defibrillation or cardioversion, or cardiac pacing.'}, {'measure': 'Number of Participants With Heparin Induced Thrombocytopenia', 'timeFrame': 'Baseline to 28 days after last dose of study drug', 'description': 'Thrombocytopenia was defined as a disorder in which there is an abnormally low platelet count. A normal platelet count ranged from 150,000 to 450,000 platelets per micro liter of blood.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Death or Myocardial Infarction (MI)', 'timeFrame': 'Baseline to 28 days after last dose of study drug'}, {'measure': 'Number of Participants With Major Bleeding Events', 'timeFrame': 'Baseline to 28 days after last dose of study drug', 'description': 'Bleeding events were considered major if, accompanied by a decrease in hemoglobin of more than or equal to 2 grams/deciliter (g/dL) in connection with clinical symptoms; a transfusion was required; bleeding led to interruption of treatment or death; or intracranial bleeding.'}, {'measure': 'Number of Participants With Minor Bleeding Events', 'timeFrame': 'Baseline to 28 days after last dose of study drug', 'description': 'Bleeding events like hematuria, wound hematoma or injection site hematoma which did not fulfill the criteria for a major bleeding episode were classified as minor bleeding.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dalteparin non-ST segment elevated acute coronary syndromes'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6301088&StudyName=Effectiveness%20And%20Safety%20Of%20Dalteparin%20In%20Patients%20With%20Acute%20Coronary%20Syndromes%20Without%20ST%20Elevations%20In%20Clinical%20Practice', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To collect data on safety and effectiveness of dalteparin in the management of non-ST segment elevated acute coronary syndromes in nursing home patients who will be treated conservatively (without percutaneous corornary intervention \\[PCI\\] or coronary artery bypass graft \\[CABG\\] within 48 hours).', 'detailedDescription': 't'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients management of non-ST segment elevated acute coronary syndromes in nursing home who will be treated conservatively (without percutaneous corornary intervention \\[PCI\\] or coronary artery bypass graft \\[CABG\\] within 48 hours).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients of 18 years or more presenting with chest pain will be potentially eligible for inclusion in the study if they satisfy the criteria for unstable coronary artery disease per the investigator's routine practice and have received at least one injection of Fragmin (dalteparin sodium) as part of routine clinical practice and is expected to be treated conservatively (without PCI or CABG within 48 hours) during the index hospitalization.\n* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\n* Patients who are contraindicated to receive this agent per the local approved prescribing information."}, 'identificationModule': {'nctId': 'NCT00922766', 'briefTitle': 'Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice', 'orgStudyIdInfo': {'id': 'A6301088'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1.0', 'interventionNames': ['Drug: Dalteparin']}], 'interventions': [{'name': 'Dalteparin', 'type': 'DRUG', 'description': 'Patients prescribed dalteparin for non-ST segment elevated acute coronary syndromes in nursing home patients who will be treated conservatively (without corornary intervention \\[PCI\\] or coronary artery bypass graft \\[CABG\\] within 48 hours).', 'armGroupLabels': ['1.0']}]}, 'contactsLocationsModule': {'locations': [{'zip': '380 051', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '395004', 'city': 'Surat', 'state': 'Gujarat', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '125 001', 'city': 'Hisar', 'state': 'Haryana', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.15394, 'lon': 75.72294}}, {'zip': '125005', 'city': 'Hisar', 'state': 'Haryana', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.15394, 'lon': 75.72294}}, {'zip': '562114', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '575 018', 'city': 'Manglore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Pfizer Investigational Site'}, {'zip': '570 020', 'city': 'Mysore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 12.29791, 'lon': 76.63925}}, {'zip': '440017', 'city': 'Nagpur', 'state': 'Maharahtra', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '3', 'city': 'Nashik', 'state': 'Maharahtra', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'zip': '421501', 'city': 'Ambernath (E)', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Pfizer Investigational Site'}, {'zip': '440 001', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '440 010', 'city': 'Nagpur', 'state': 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'Maharashtra', 'country': 'India', 'facility': 'Pfizer Investigational Site'}, {'city': 'Thane', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 19.19704, 'lon': 72.96355}}, {'zip': '334003', 'city': 'Bikaner', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 28.01762, 'lon': 73.31495}}, {'zip': '302 012', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '302019', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '600 035', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '700 019', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}