Ignite Creation Date:
2024-05-06 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03329261
Status:
COMPLETED
Last Update Posted:
2019-12-23
First Post:
2017-10-14
Brief Title:
Incidence of Major Cardiovascular Events in Diabetic Patients With ACS Undergoing Coronary Angioplasty and Treated With Clopidogrel 150 mg Versus 75 mg
Sponsor:
Laboratoires Teriak
Organization:
Laboratoires Teriak
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDASCOP 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 CVATIA 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
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 CVATIA 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None