Ignite Creation Date:
2024-05-05 @ 11:01 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01231035
Status:
COMPLETED
Last Update Posted:
2011-07-25
First Post:
2010-10-29
Brief Title:
REsponsiveness to CLOpidogrel and Stent-related Events in Acute Coronary Syndromes RECLOSE 2 - ACS
Sponsor:
Careggi Hospital
Organization:
Careggi Hospital
Study Overview
Official Title:
REsponsiveness to CLOpidogrel and Stent-related Events in Acute Coronary Reclose 2-ACS Registry
Status:
COMPLETED
Status Verified Date:
2011-07
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:
RECLOSE2-ACS
Brief Summary:
The main objective of the project is to assess the long-term prognostic impact of residual platelet reactivity after optimal antiplatelet therapy in a large cohort of patients with acute coronary syndrome undergoing invasive strategy
Follow-up length will be at least 24 months The primary end-point of the study will be a composite of death myocardial infarction urgent target vessel revascularization stent thrombosis or stroke
Follow-up length will be at least 24 months The primary end-point of the study will be a composite of death myocardial infarction urgent target vessel revascularization stent thrombosis or stroke
Detailed Description:
This study is mainly based on a registry of 2000 consecutive patients with acute coronary syndrome who received invasive treatment and for whom platelet reactivity after clopidogrel treatment will be prospectively assessed
In the acute phase blood samples for platelet reactivity assessment will be obtained 12 to 18 hours from 600 mg clopidogrel loading Platelet-rich plasma obtained by centrifuging whole blood for 10 min at 200 g was stimulated with 10 M adenosine 5-diphosphate ADP and residual aggregation will be assessed using a APACT 4 light transmittance aggregometer Platelet aggregation according to the Borns method will be evaluated considering the maximal percentage of platelet aggregation in response to stimulus Patients with platelet aggregation by 10 µmol ADP 90th percentile of controls 70 will be defined as non-responders The assessment of platelet reactivity will be repeated at 6 months The importance of concomitant aspirin resistance will be also evaluated in such of patients
In the acute phase blood samples for platelet reactivity assessment will be obtained 12 to 18 hours from 600 mg clopidogrel loading Platelet-rich plasma obtained by centrifuging whole blood for 10 min at 200 g was stimulated with 10 M adenosine 5-diphosphate ADP and residual aggregation will be assessed using a APACT 4 light transmittance aggregometer Platelet aggregation according to the Borns method will be evaluated considering the maximal percentage of platelet aggregation in response to stimulus Patients with platelet aggregation by 10 µmol ADP 90th percentile of controls 70 will be defined as non-responders The assessment of platelet reactivity will be repeated at 6 months The importance of concomitant aspirin resistance will be also evaluated in such of patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Apice | OTHER_GRANT | Ministry of Health Italy | None |