Angioplasty to Blunt the Rise of Troponin in Acute Coronary Syndrome (ACS)

NCT00442949 | Completed DMC

• 1 other identifier: P050705
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Release of troponin evaluated by the peak of troponin during the hospital phase.Because of its sensitivity and specificity as well as its widespread use in routine practice, rise in troponin levels is the main assessment criteria of this study. We plan to demonstrate a significantly altered distribution of the troponin release as evaluated by the peak of troponin for each patient during the hospitalization period (from randomization to cardiologic unit discharge), in the two arms of the trial.

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndrome; Angioplasty; Abciximab; Troponin release

Outcome Measures

Primary Outcomes (1)

• Release of troponin evaluated by the peak of troponin during the hospital phase

  during the hospital phase

Secondary Outcomes (1)

• Death, MIs and urgent revascularizations will be recorded as ischemic events during 1month following randomization.

  during 1month following randomization

Study Arms (2)

2

ACTIVE COMPARATOR

Catheterization immediate PCI

Procedure: Catheterization immediate PCI

1

EXPERIMENTAL

delayed PCI

Procedure: delayed PCI

Interventions

Catheterization immediate PCI PROCEDURE

Catheterization immediate PCI

2

delayed PCI PROCEDURE

delayed PCI

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man over 18 or non-pregnant woman over 18.
• Patient hospitalized for severe acute coronary syndrome. To be selected patients will need to have at least 2 criteria for acute coronary syndrome AND a TIMI score \> 3 for severity of ACS.
• ACS is defined by at least two of the following diagnostic criteria :
• ischemic symptom
• electrocardiographic abnormalities in the ST segment (depression or transitory elevation of at least 0.1 mV), or in the T waves, at least in two contiguous leads positive troponin (as defined locally).
• Severity of ACS is defined by a TIMI score \> 3
• indication for catheterization agreed and possible within the following 8 hours.
• signed consent form

You may not qualify if:

• Patients that would require immediate catheterization for ongoing refractory ischemia, major arrhythmias, or hemodynamic instability are not eligible for the study.
• Anticoagulant therapy with antivitamin K within 5 days preceding randomization
• Thrombolytic therapy during the preceding 24 hours
• Upstream treatment by a GPIIb/IIIa inhibitor
• ReoPro should not be administered to patients with known sensitivity to abciximab, to any component of the product or to murine monoclonal antibodies. Because inhibition of platelet aggregation increases the risk of bleeding, ReoPro is contra-indicated in the following clinical situations: active internal bleeding; history of cerebrovascular accident within two years; recent (within two months) intracranial or intraspinal surgery or trauma; recent (within two months) major surgery; intracranial neoplasm, arteriovenous malformation or aneurysm; known bleeding diathesis or severe uncontrolled hypertension; pre-existing thrombocytopenia; vasculitis; hypertensive or diabetic retinopathy; severe hepatic or severe renal failure.
• Woman nursing

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Institut de Cardiologie - Hôpital Pitié-Salpétrière

Paris, 75013, France

Location

Related Publications (2)

• Barthelemy O, Cayla G, Silvain J, O'Connor SA, Bellemain-Appaix A, Beygui F, Sideris G, Varenne O, Collet JP, Vicaut E, Montalescot G; ABOARD Investigators. Optimal time for catheterization in NSTE-ACS patients with impaired renal function: insights from the ABOARD Study. Int J Cardiol. 2013 Sep 10;167(6):2646-52. doi: 10.1016/j.ijcard.2012.06.126. Epub 2012 Jul 12.

  PMID: 22795712 DERIVED

• Montalescot G, Cayla G, Collet JP, Elhadad S, Beygui F, Le Breton H, Choussat R, Leclercq F, Silvain J, Duclos F, Aout M, Dubois-Rande JL, Barthelemy O, Ducrocq G, Bellemain-Appaix A, Payot L, Steg PG, Henry P, Spaulding C, Vicaut E; ABOARD Investigators. Immediate vs delayed intervention for acute coronary syndromes: a randomized clinical trial. JAMA. 2009 Sep 2;302(9):947-54. doi: 10.1001/jama.2009.1267.

  PMID: 19724041 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Gilles MONTALESCOT, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 5, 2007
• Study Start: August 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: February 12, 2009

Record last verified: 2008-04

Locations

FR (1)