Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT02809820
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2016-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Beta-blockade on Platelet Aggregation in Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000077261', 'term': 'Carvedilol'}, {'id': 'D008790', 'term': 'Metoprolol'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2016-06-21', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet aggregation', 'timeFrame': '30 days', 'description': 'Platelet aggregation induced by epinephrine is measured by Light Transmission Aggregometry (LTA)'}], 'secondaryOutcomes': [{'measure': '30-days platelet aggregation', 'timeFrame': '30 days', 'description': 'Platelet aggregation induced by Adenosine Diphosphate (ADP) is measured by Light Transmission Aggregometry (LTA)'}, {'measure': '30-days clinical events', 'timeFrame': '30 days', 'description': 'Major adverse cardiac events (MACE) and bleedings will be evaluated'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ACS', 'Beta Blockers', 'platelet aggregation', 'light transmission aggregometry', 'Beta-Adrenergic Blockers'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '24730697', 'type': 'BACKGROUND', 'citation': 'Bonten TN, Plaizier CE, Snoep JJ, Stijnen T, Dekkers OM, van der Bom JG. Effect of beta-blockers on platelet aggregation: a systematic review and meta-analysis. Br J Clin Pharmacol. 2014 Nov;78(5):940-9. doi: 10.1111/bcp.12404.'}, {'pmid': '25868659', 'type': 'BACKGROUND', 'citation': 'Ignjatovic V, Pavlovic S, Miloradovic V, Andjelkovic N, Davidovic G, Djurdjevic P, Stolic R, Iric-Cupic V, Simic I, Ignjatovic VD, Petrovic N, Smiljanic Z, Zdravkovic V, Simovic S, Jovanovic D, Nesic J. Influence of Different beta-Blockers on Platelet Aggregation in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy. J Cardiovasc Pharmacol Ther. 2016 Jan;21(1):44-52. doi: 10.1177/1074248415581175. Epub 2015 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'The Investigators will test the hypothesis that nonselective beta-blockers would have a more pronounced effect on platelet aggregation than selective beta-blockers in patients with acute coronary syndrome treated with dual anti platelet therapy.', 'detailedDescription': 'In patients with acute coronary syndrome (ACS) beta-blockers are recommended for secondary prevention. It is known that catecholamine levels can potentiate platelet reactivity and beta-blocking agents may also affect platelet aggregation. This effect is mainly mediated by adrenergic receptors on platelets. This suggests that nonselective beta-blockers would have a more pronounced effect on platelet aggregation than selective beta-blockers. However, little is known about the effect of beta-blockers on platelet aggregation in patients with cardiovascular disease and, to date, nothing is known in the setting of ACS.\n\nThe aim of the present study is to evaluate the effect of selective and nonselective beta-blockers on platelet aggregation in ACS patients treated with dual anti platelet therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute Coronary Syndrome\n* Current dual anti platelet treatment with acetylsalicylic acid and Ticagrelor\n\nExclusion Criteria:\n\n* ongoing prasugrel, ticlopidine or clopidogrel therapy\n* Creatinine Clearance \\< 30 ml/min/1.73mm2\n* Moderate to severe anemia Hemoglobin \\< 10 mg/dl\n* Platelet count \\>600000/mm3 or \\<150000/mm3 or hematocrit \\>50% or \\<25%\n* concomitant neoplastic or immune-mediated pathologies\n* severe pulmonary pathologies\n* contraindication to beta blocker therapy.'}, 'identificationModule': {'nctId': 'NCT02809820', 'acronym': 'PLATE-BLOCK', 'briefTitle': 'Effects of Beta-blockade on Platelet Aggregation in Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Effects of Selective and Nonselective Beta-blockade on Platelet Aggregation in Patients With Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'CE-9/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Carvedilol', 'description': 'Patients who have documented ACS, who are on dual antiplatelet therapy and are randomized to assume carvedilol.', 'interventionNames': ['Drug: Carvedilol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metoprolol', 'description': 'Patients who have documented ACS, who are on dual antiplatelet therapy and are randomized to assume metoprolol.', 'interventionNames': ['Drug: Metoprolol']}], 'interventions': [{'name': 'Carvedilol', 'type': 'DRUG', 'otherNames': ['Selective beta-blocker'], 'description': 'Patients randomized to this group will receive carvedilol at the highest dose tolerated', 'armGroupLabels': ['Carvedilol']}, {'name': 'Metoprolol', 'type': 'DRUG', 'otherNames': ['Non Selective beta-blocker'], 'description': 'Patients randomized to this group will receive metoprolol at the highest dose tolerated', 'armGroupLabels': ['Metoprolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'Federico II University of Naples', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Giovanni Esposito, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federico II University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Giovanni Esposito', 'investigatorAffiliation': 'Federico II University'}}}}