Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03329261
Recruitment Status : Not yet recruiting
First Posted : November 1, 2017
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Dacima Consulting
Information provided by (Responsible Party):
Laboratoires Teriak

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 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 NSTEMI - Non-ST Segment Elevation MI Coronary Angioplasty Drug: Clopidogrel Phase 4

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 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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A comparative, interventional, multicenter, randomized, prospective, two-arm study with monotherapy in two different doses
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Active Comparator: Arm 1 (single dose)
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
COPIGREL® - clopidogrel dosed at 75 mg per tablet
Other Name: COPIGREL®

Active Comparator: Arm 2 (double dose)
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
Other Name: COPIGREL®




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329261


Contacts
Layout table for location contacts
Contact: HABIB HAOUALA, Cardiologist 00216 98 31 81 26 haoualahabib@yahoo.fr

Sponsors and Collaborators
Laboratoires Teriak
Dacima Consulting

Layout table for additonal information
Responsible Party: Laboratoires Teriak
ClinicalTrials.gov Identifier: NCT03329261     History of Changes
Other Study ID Numbers: TERIAK-001
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Platelet Aggregation Inhibitors
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Clopidogrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs