Clinical trial NCT01231035: REsponsiveness to CLOpidogrel and Stent-related Events in Acute Coronary Syndromes (RECLOSE 2 - ACS)
Official title: REsponsiveness to CLOpidogrel and Stent-related Events in Acute Coronary. Reclose 2-ACS Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cardiac Syndrome
Stent Thrombosis
Platelet Function
Antiplatelet Therapy
Keywords: acute cardiac syndrome
stent thrombosis
platelet function
antiplatelet therapy
Lead sponsor: Careggi Hospital
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 1789
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with acute coronary syndrome who received invasive treatment and for whom platelet reactivity after clopidogrel treatment will be prospectively assessed.

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: long-term prognostic impact of residual platelet reactivity
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Careggi Hospital, Department of Heart and Vessels
Study officials:
affiliation: Careggi Hospital, Division of Invasive Cardiology
name: David Antoniucci, MD
role: STUDY_DIRECTOR
References:
citation: Parodi G, Marcucci R, Valenti R, Gori AM, Migliorini A, Giusti B, Buonamici P, Gensini GF, Abbate R, Antoniucci D. High residual platelet reactivity after clopidogrel loading and long-term cardiovascular events among patients with acute coronary syndromes undergoing PCI. JAMA. 2011 Sep 21;306(11):1215-23. doi: 10.1001/jama.2011.1332.