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Incidence of Major Cardiovascular Events in Diabetic Patients With ACS Undergoing Coronary Angioplasty and Treated With Clopidogrel 150 mg Versus 75 mg (IDASCOP 1)

Primary Purpose

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

Status

Completed

Phase

Phase 4

Locations

Tunisia

Study Type

Interventional

Intervention

Clopidogrel

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

HMPIT

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm 1 (single dose)

Arm 2 (double dose)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Major Cardiovascular Events (MACE)

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

Secondary Outcome Measures

Bleeding Events

All bleeding events (digestive, cerebral, other locations)

Heart Failure Readmission

Incidence of heart failure hospital readmissions

Global Death

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

Incidence of Adverse Events

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

Full Information

NCT ID

NCT03329261

First Posted

October 14, 2017

Last Updated

December 20, 2019

Sponsor

Laboratoires Teriak

1. Study Identification

Unique Protocol Identification Number

NCT03329261

Brief Title

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

Acronym

IDASCOP 1

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

December 7, 2017 (Actual)

Primary Completion Date

March 24, 2019 (Actual)

Study Completion Date

December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratoires Teriak

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

167 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 (single dose)

Arm Type

Active Comparator

Arm Description

Arm Title

Arm 2 (double dose)

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Other Intervention Name(s)

COPIGREL®

Intervention Description

COPIGREL® - clopidogrel dosed at 75 mg per tablet

Primary Outcome Measure Information:

Title

Major Cardiovascular Events (MACE)

Description

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

Time Frame

1 year after coronary intervention

Secondary Outcome Measure Information:

Title

Bleeding Events

Description

All bleeding events (digestive, cerebral, other locations)

Time Frame

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

Title

Heart Failure Readmission

Description

Incidence of heart failure hospital readmissions

Time Frame

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

Title

Global Death

Description

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

Title

Incidence of Adverse Events

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

HMPIT

City

Ben Arous

Country

Tunisia

12. IPD Sharing Statement

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

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