Skip to main content
OpenTrials
Completed

NCT Number: NCT01231035

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Cardiac Syndrome Antiplatelet Therapy Platelet Function Stent Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Careggi Hospital, Department of Heart and Vessels

Florence, 50134, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. long-term prognostic impact of residual platelet reactivity

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

Careggi Hospital

Other

Registry information

Official study title

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

Acronym: RECLOSE2-ACS

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 1, 2010
Registry last updated
Jul 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.