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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01231035
Acronym
RECLOSE2-ACS
Enrollment
1789
Registered
2010-11-01
Start date
2008-09-30
Completion date
2011-03-31
Last updated
2011-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

acute cardiac syndrome, stent thrombosis, platelet function, antiplatelet therapy

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.

Interventions

None listed

Sponsors

Careggi Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
long-term prognostic impact of residual platelet reactivity24 monthsto 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026