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Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes?

NCT02750579 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 740

Last updated 2018-04-09

No results posted yet for this study

Summary

Percutaneous coronary intervention (PCI) is the cornerstone of the care of intermediate and high-risk non ST-elevation acute coronary syndromes (NSTE ACS). Revascularization reduces the rate of cardiovascular death and recurrent myocardial infarction in this clinical setting. The recommendation regarding the timing of intervention in this clinical setting is derived from old trials and has a weak level of evidence. In fact, there are no conclusive randomized trials in the contemporary era providing guidance on the optimal timing of intervention. In addition, the optimal timing of this critical intervention has not been studied since the development of new P2Y12-ADP receptor antagonists and the controversy surrounding the use of pretreatment with a P2Y12-ADP receptor antagonist before intervention. Early intervention in intermediate and high-risk non ST-elevation ACS is not well validated to date. In addition, the recent changes in the use of pretreatment with P2Y12-ADP receptor antagonists may impact on the potential benefit of an early intervention.

Based on these evidences, we hypothesize that with the current protocols of care without pretreatment with a P2Y12-ADP receptor antagonist, an early PCI (\<2 hours) would be superior to a delayed (between 12 to 72 hours) PCI in the setting of intermediate or high-risk non-ST elevation acute coronary syndrome to prevent cardiovascular death and ischemic recurrences.

Conditions

  • Acute Coronary Syndrome

Interventions

PROCEDURE

Percutaneous coronary intervention for revascularization

Percutaneous coronary intervention for revascularization with anticoagulant and antiplatelet therapy (routine care)

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Laurent Bonello, MD · assistance Public Hopitaux de Marseille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-05
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02750579 on ClinicalTrials.gov