Status:
COMPLETED
Incidence of Major Cardiovascular Events in Diabetic Patients With ACS Undergoing Coronary Angioplasty and Treated With Clopidogrel 150 mg Versus 75 mg
Lead Sponsor:
Laboratoires Teriak
Conditions:
Diabetes Mellitus, Type 2
NSTEMI - Non-ST Segment Elevation MI
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
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 requi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female aged between 18 to 75 years old.
- Proven ACS requiring PTCA within 1 week of inclusion. The ACS should be without ST-segment elevation (presence of chest pain with ST-segment or T-wave changes without sustained ST segment elevation) with elevation of cardiac biomarkers of MI (positive troponins).
- Coronary angiography showing at least one coronary lesion, whether mono, bi or multi-truncate
- Type 2 diabetes confirmed for at least one year
- Patient candidate for treatment with Clopidogrel
- Informed consent of patients
- Non-Inclusion Criteria:
- Non-consenting patient and/or participating in another clinical study
- ACS with ST segment elevation (STEMI)
- History of digestive or cerebral bleeding with antiplatelet agents or anticoagulants
- Insulin-dependent diabetes mellitus (IDDM)
- Diabetic requiring insulin
- Patient in cardiogenic shock
- Patient under treatment with anti-glycoprotein IIb/IIIa or stopped less than 72 hours prior to inclusion
- Previously treated with clopidogrel or thrombolytics
- Patients programmed for surgery in less than 6 months
- Ischemic stroke less than 6 weeks old
- History of haemorrhagic stroke (regardless of time)
- Patients under or candidates for Vitamin K antagonist (VKA)
- Patients under another antiplatelet agent (Ticlopidine, Prasugrel)
- Patients with a contraindication to clopidogrel (hypersensitivity to the active substance or to any of the excipients, severe hepatic impairment, progressive hemorrhagic lesion such as peptic ulcer or intracranial hemorrhage)
- Under omeprazole treatment, or considered during the study
- Anemia (Hb \<12g/dl)
- Thrombocytopenia with less than 100000 cells/mm3
- Serum creatinine greater than 200 μmol/l
- Pregnancy and/or breast-feeding
- Severe renal impairment
- Exclusion criteria:
- Non-compliance with treatment (treatment compliance \<80%)
- AE/SAE requiring cessation of treatment
- Planning a CABG
- Occurrence of pregnancy during the study
Exclusion
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2019
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT03329261
Start Date
December 7 2017
End Date
December 20 2019
Last Update
December 23 2019
Active Locations (1)
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1
HMPIT
Ben Arous, Tunisia