A Phase 4 interventional study of Clopidogrel in Diabetes Mellitus, Type 2, NSTEMI - Non-ST Segment Elevation MI and Coronary Angioplasty, sponsored by Laboratoires Teriak. Completed at 1 site in Tunisia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-23.
Sponsored by Laboratoires Teriak · Phase 4, Interventional, and Treatment
Acute Coronary Syndrome (ACS) is triggered by the rupture of an atherosclerotic plaque that results in a platelet aggregation reaction in the coronary artery. The administration of antiplatelet agents starting from the acute phase of the disease has helped reduce the risk of ischemic relapse both during initial and long-term hospitalization.
Management of clopidogrel following an ischemic event has been the subject of several treatment regimens ranging from a single continuous dose to a sequential double dose of between 7 and 30 days. The CURRENT-OASIS 7 therapeutic trial showed a benefit of clopidogrel double dose in reducing the risk of myocardial intervention (MI) and the composite outcome: cardiovascular mortality, MI, or stroke (CVA/TIA) at 30 days. However, the study protocol was interested in all ACSs, regardless of the Type 2 Diabetes Mellitus (T2DM) status in selected patients. Also, doubling of clopidogrel dose was maintained over 7 days after angioplasty. The literature describes an increased cardiovascular risk in type II diabetics in secondary prevention. No previous study has evaluated the effect of clopidogrel double dose given for 1 month on the reduction of this risk in the long-term in diabetic patients.
Thus, the objective of this study is to evaluate the efficacy and safety of clopidogrel double dose, given for 1 month in ACS in the diabetic patient.
The study is an open label, multicentric clinical trial. Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).
Non-Inclusion Criteria:
Exclusion criteria:
Will receive a clopidogrel loading dose of 600 mg PO, then a daily dose of clopidogrel 75 mg PO until the angioplasty is performed. After coronary intervention, a daily dose of clopidogrel 150 mg PO for 7 days will be given, followed by a daily single dose of clopidogrel (75 mg PO) for 21 days. Maintenance therapy will be clopidogrel daily dose of 75 mg PO thereafter, until the end of the study.
Drug: Clopidogrel
Will receive a clopidogrel loading dose of 600 mg PO, then a daily dose of clopidogrel 75 mg PO until the angioplasty is performed. After coronary intervention, a daily dose of clopidogrel 150 mg PO for 7 days will be given, followed by a daily double dose of clopidogrel (150 mg PO) for 21 days. Maintenance therapy will be clopidogrel daily dose of 75 mg PO thereafter, until the end of the study.
Drug: Clopidogrel
COPIGREL® - clopidogrel dosed at 75 mg per tablet
Also known as: COPIGREL®
Major Cardiovascular Events (MACE)
Incidence of major cardiovascular events including cardiac death, MI, cerebrovascular accident (CVA), revascularization (PTCA, GABG), stent thrombosis.
Time frame: 1 year after coronary intervention
Bleeding Events
All bleeding events (digestive, cerebral, other locations)
Time frame: At 1, 3, 6, 9 and 12 months from patient enrollment
Heart Failure Readmission
Incidence of heart failure hospital readmissions
Time frame: At 1, 3, 6, 9 and 12 months from patient enrollment
Global Death
Incidence of death of all causes (death of cardiovascular origin and death of non-cardiovascular origin)
Time frame: At 1, 3, 6, 9 and 12 months from patient enrollment
Incidence of Adverse Events
Incidence of Adverse Events (AE) including Serious Adverse Events (SAE)
Time frame: At 1, 3, 6, 9 and 12 months from patient enrollment
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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