Skip to main content
OpenTrials
Completed

NCT Number: NCT03329261

Incidence of Major Cardiovascular Events in Diabetic Patients With ACS Undergoing Coronary Angioplasty and Treated With Clopidogrel 150 mg Versus 75 mg

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Coronary Angioplasty Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Infarction Ischemia Metabolic Diseases Myocardial Infarction Myocardial Ischemia NSTEMI - Non-ST Segment Elevation MI Necrosis Non-ST Elevated Myocardial Infarction Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HMPIT

Ben Arous, Tunisia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

COPIGREL® - clopidogrel dosed at 75 mg per tablet

Other names: COPIGREL®

Primary outcomes

  1. Major Cardiovascular Events (MACE)

    Time frame: 1 year after coronary intervention

    Incidence of major cardiovascular events including cardiac death, MI, cerebrovascular accident (CVA), revascularization (PTCA, GABG), stent thrombosis.

Secondary outcomes

  1. Bleeding Events

    Time frame: At 1, 3, 6, 9 and 12 months from patient enrollment

    All bleeding events (digestive, cerebral, other locations)

  2. Heart Failure Readmission

    Time frame: At 1, 3, 6, 9 and 12 months from patient enrollment

    Incidence of heart failure hospital readmissions

  3. Global Death

    Time frame: At 1, 3, 6, 9 and 12 months from patient enrollment

    Incidence of death of all causes (death of cardiovascular origin and death of non-cardiovascular origin)

  4. Incidence of Adverse Events

    Time frame: At 1, 3, 6, 9 and 12 months from patient enrollment

    Incidence of Adverse Events (AE) including Serious Adverse Events (SAE)

Sponsors and collaborators

Lead sponsor

Laboratoires Teriak

Industry

Registry information

Official study title

Incidence Des évènements cArdiovasculaires majeurS Chez Les Patients COronariens diabétiques Subissant Une angioPlastie Coronaire et traités Par Clopidogrel à la Dose 150 mg Versus 75 mg

Acronym: IDASCOP 1

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2017
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.