Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-02-25 @ 4:15 AM
Study NCT ID:
NCT01491061
Status:
UNKNOWN
Last Update Posted:
2013-03-07
First Post:
2011-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ranolazine Loading to Prevent PCI-induced Myocardial Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069458', 'term': 'Ranolazine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-06', 'studyFirstSubmitDate': '2011-12-08', 'studyFirstSubmitQcDate': '2011-12-09', 'lastUpdatePostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of PCI-induced myocardial infarction', 'timeFrame': 'Up to 48 hours after PCI', 'description': 'Occurrence of peri-procedural myocardial infarction (i.e. creatine kinase-MB\\>3 times the upper reference limit)'}], 'secondaryOutcomes': [{'measure': 'Assessment of post-PCI peak values of markers of myocardial damage', 'timeFrame': 'Baseline and 48 hours after PCI', 'description': 'Changes after percutaneous coronary intervention in absolute values of creatine kinase, creatine kinase-MB, myoglobin, and troponin I'}, {'measure': 'Rate of 30-day MACE', 'timeFrame': 'Up to 30 days after PCI', 'description': '30-day incidence of major adverse cardiac events (MACE-death, myocardial infarction, target vessel revascularization)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['periprocedural myocardial infarction', 'ranolazine'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'It has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7 days can significantly reduce procedural myocardial injury in elective percutaneous coronary intervention (PCI). The investigators tested the hypothesis that twice overnight high-dose ranolazine loading before PCI can reduce the peri-procedural myocardial ischemic damage similarly to long-term pre-treatment with standard doses.', 'detailedDescription': 'Background\n\nRanolazine is a novel antianginal drug that reduces intracellular sodium and calcium accumulation during ischemia thus limiting ischemic injury.\n\nIt has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7 days can significantly reduce procedural myocardial injury in elective percutaneous coronary intervention.\n\nIt remains unknown, however, which of these two therapeutic approaches is more effective after PCI.\n\nPurpose\n\nThe primary objective of this study is to test the hypothesis that twice overnight high-dose ranolazine loading before PCI can reduce the peri-procedural myocardial ischemic damage similarly to long-term pre-treatment with standard doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Angiographically-proven coronary artery disease\n* Class I indication to elective percutaneous coronary intervention\n* Stable conditions\n* No recent acute coronary syndromes\n* Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I)\n* Able to understand and willing to sign the informed consent form\n\nExclusion Criteria:\n\n• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before'}, 'identificationModule': {'nctId': 'NCT01491061', 'acronym': 'TWILIGHT', 'briefTitle': 'Ranolazine Loading to Prevent PCI-induced Myocardial Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'TWice overnIght High-dose ranoLazIne Pretreatment for preventinG Myocardial iscHemic Damage in Patients With Stable Angina Undergoing percuTaneous Coronary Intervention', 'orgStudyIdInfo': {'id': '653/2011/D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ranolazine', 'description': 'Administration of two preprocedural doses of Ranolazine 12 hours apart (1,000 mg the night before PCI and 1,000 mg prior to PCI)', 'interventionNames': ['Drug: Ranolazine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ranolazine', 'type': 'DRUG', 'otherNames': ['Ranexa TM, Gilead, USA'], 'description': 'os, 1,000 mg twice 12 hours apart prior to PCI', 'armGroupLabels': ['Ranolazine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'os, two doses 12 hours apart prior to PCI', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00100', 'city': 'Rome', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Marazzi, MD', 'role': 'CONTACT', 'email': 'giuseppe.marazzi@yahoo.com', 'phone': '+39 335 8381320'}], 'facility': 'San Raffaele Pisana', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Francesco Pelliccia, MD', 'role': 'CONTACT', 'email': 'f.pelliccia@mclink.it', 'phone': '+393483392006'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Francesco Pelliccia', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}