REsponsiveness to CLOpidogrel and Stent-related Events in Acute Coronary Syndromes (RECLOSE 2 - ACS)

Stent Thrombosis Clinical Trial

— RECLOSE2-ACS  

Official title:

REsponsiveness to CLOpidogrel and Stent-related Events in Acute Coronary. Reclose 2-ACS Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231035
• Other study ID #: RECLOSE 2-ACS
• Secondary ID: Apice
• Status: Completed
• Phase: N/A
• First received: October 29, 2010
• Last updated: July 22, 2011
• Start date: September 2008
• Est. completion date: March 2011

Study information

• Verified date: July 2011
• Source: Careggi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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 Born's 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1789
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• acute coronary syndrome

• invasive treatment

Exclusion Criteria:

• in-hospital death that was not due to stent thrombosis,

• anticipated poor compliance to dual antipletelet treatment for at least 6 months,

• premature discontinuation of clopidogrel therapy.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Cardiac Syndrome
• Antiplatelet Therapy
• Platelet Function
• Stent Thrombosis
• Thrombosis

Locations

Country	Name	City	State
Italy	Careggi Hospital, Department of Heart and Vessels	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Careggi Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Antoniucci D,Parodi G,Valenti R,Marcucci R,Giusti B,Migliorini A,Buonamici P,Abbate R High residual platelect reactivity after clopidogrel loading and long-term thrombotic events in patients with acute coronary syndrome undergoing invasive treatment:the RECLOSE 2-ACS Trial. Eurointervention 2011;7(suppl M):172

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	long-term prognostic impact of residual platelet reactivity	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.	24 months	Yes