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

NCT03329261 | Completed Phase 4

• 1 other identifier: TERIAK-001
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; NSTEMI - Non-ST Segment Elevation MI; Coronary Angioplasty

Outcome Measures

Primary Outcomes (1)

• Major Cardiovascular Events (MACE)

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

  1 year after coronary intervention

Secondary Outcomes (4)

• Bleeding Events

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

• Heart Failure Readmission

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

• Global Death

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

• Incidence of Adverse Events

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

Study Arms (2)

Arm 1 (single dose)

ACTIVE COMPARATOR

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

Arm 2 (double dose)

ACTIVE COMPARATOR

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

Interventions

Clopidogrel DRUG

COPIGREL® - clopidogrel dosed at 75 mg per tablet

Also known as: COPIGREL®

Arm 1 (single dose); Arm 2 (double dose)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged between 18 to 75 years old.
• 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-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
• 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)

You may not qualify if:

• Non-compliance with treatment (treatment compliance \<80%)
• AE/SAE requiring cessation of treatment
• Planning a CABG
• Occurrence of pregnancy during the study

Sponsors & Collaborators

• Laboratoires Teriak: lead

Study Sites (1)

HMPIT

Ben Arous, Tunisia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-ST Elevated Myocardial Infarction

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A comparative, interventional, multicenter, randomized, prospective, two-arm study with monotherapy in two different doses

Study Record Dates

• First Submitted: October 14, 2017
• First Posted: November 1, 2017
• Study Start: December 7, 2017
• Primary Completion: March 24, 2019
• Study Completion: December 20, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Locations

TU (1)