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

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ClinicalTrials.gov Identifier: NCT02750579
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief 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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Procedure: Percutaneous coronary intervention for revascularization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 740 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes?
Actual Study Start Date : September 5, 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Arm Intervention/treatment
Active Comparator: Control group
control group: Percutaneous coronary intervention for revascularization delayed intervention (12 to 72 hours)
Procedure: Percutaneous coronary intervention for revascularization
Percutaneous coronary intervention for revascularization with anticoagulant and antiplatelet therapy (routine care)

Experimental: experimental group
experimental group: early Percutaneous coronary intervention for revascularization intervention (<2 hours)
Procedure: Percutaneous coronary intervention for revascularization
Percutaneous coronary intervention for revascularization with anticoagulant and antiplatelet therapy (routine care)




Primary Outcome Measures :
  1. recurrent ischemic events [ Time Frame: 1 month ]
    compare the efficacy defined by the rate of recurrent ischemic events at 1 month of 2 therapeutic strategies: an immediate (<2 hours) versus a delayed (12-72 hours) intervention for intermediate and high-risk non ST-elevation acute coronary syndrome compare the efficacy defined by the rate of cardiovascular death and/or recurrent ischemic events at 1 month of 2 therapeutic strategies: an immediate (<2 hours) versus a delayed (12-72 hours) intervention for intermediate and high-risk non ST-elevation acute coronary syndrome

  2. cardiovascular death [ Time Frame: 1 month ]
    compare the efficacy defined by the rate of cardiovascular death at 1 month of 2 therapeutic strategies: an immediate (<2 hours) versus a delayed (12-72 hours) intervention for intermediate and high-risk non ST-elevation acute coronary syndrome



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must not be of child-bearing potential (1 year post-menopausal, contraceptive use or surgically sterile);
  • Subject with a non-ST-segment elevation ACS defined by the presence of at least 2 of the following criteria: symptoms of myocardial ischemia, electrocardiographic ST-segment abnormalities (depression or transient elevation of at least 0.1 mV) or T-wave inversion in at least in 2 contiguous leads, or an elevated cardiac troponin value (above the upper limit of normal) ;
  • Subject requiring intervention according to physician's judgment including the following criteria subject with one of the following risk factor defining intermediate and high risk ACS: diabetes mellitus, kidney failure, reduced LVEF, early post infarction angina, recent PCI, prior CABG or a GRACE risk score >109, recurrent symptoms or ischaemia on non-invasive testing (2);
  • Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital;

Exclusion Criteria:

  • - Minors or pregnant or breast-feeding women;
  • Subject with low risk ACS;
  • Subject with very high-risk ACS: refractory angina, severe heart failure, life-threatening ventricular arrhythmias, hemodynamic instability requiring immediate intervention;
  • Subject with thrombolytic therapy during the preceding 24 hours;
  • Subject with bleeding diathesis;
  • Subject with Upstream treatment by a GPIIb/IIIa inhibitor;
  • Subject under chronic anticoagulant;
  • Subject participating in another research protocol;
  • Subject not agreeing to participate;
  • Subject with contraindication to or under chronic P2Y12 receptor antagonists therapy (clopidogrel, ticagrelor and prasugrel);
  • Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization into the study defined as follows:
  • ST-segment elevation myocardial infarction is defined as a history of chest discomfort or ischemic symptoms of >20 minutes duration at rest ≤14 days prior to entry into the study with one of the following present on at least one ECG prior to randomization:

    1. ST-segment elevation ≥1 mm in two or more contiguous ECG leads.
    2. New or presumably new left bundle branch block (LBBB).
    3. ST-segment depression ≥1 mm in two anterior precordial leads (V1 through V4) with clinical history and evidence suggestive of true posterior infarction.
  • Have cardiogenic shock (systolic blood pressure <90 mm Hg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion);
  • Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750579


Locations
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France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13015
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Principal Investigator: Laurent Bonello, MD assistance Public Hopitaux de Marseille

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02750579     History of Changes
Other Study ID Numbers: 2016-A00379-42
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases