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

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Catheterization immediate PCI

delayed PCI

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute coronary syndrome, Angioplasty, Abciximab, Troponin release

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Institut de Cardiologie - Hôpital Pitié-Salpétrière

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

Catheterization immediate PCI

delayed PCI

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00442949

First Posted

March 2, 2007

Last Updated

February 11, 2009

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00442949

Brief Title

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

Acronym

ABOARD

Official Title

Angioplasty to Blunt the Rise of Troponin in Acute Coronary Syndromes Randomized for an Immediate or Delayed Intervention (The ABOARD Study)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

We propose to evaluate the optimal moment for catheterization in patients presenting with acute coronary syndromes by comparing rapid catheterization on the day of admission (within 8 hours of admission, with an average time close to 3 hours, as in the rapid strategy arm of the ISAR-COOL trial) with a slower approach where the examination is scheduled for the next working day (8 to 60 hours post admission, with an average close to 24 hours). Patients included will present with severe unstable angina defined as a TIMI score > 3 All patients must present with an indication for catheterization and they will receive the same optimal pharmacological treatment including abciximab (ReoPro*) when undergoing PCI and started just before the procedure as indicated in the label of the drug (substitution by another drug of the class, eptifibatide or tirofiban, is not possible in the catheterization laboratory according to the labels of these two other drugs). Randomization will evaluate only time to catheterization: rapidly, as soon as possible following admission (within 8 hours of admission) versus a delayed approach (8 to 60 hours following admission). The goal of randomization is to determine the ideal time to catheterization while indications for catheterization, pharmacological treatment, and patient care remain constant. This is a pragmatic study aiming to compare 2 different strategies in the management of ACS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

Acute coronary syndrome, Angioplasty, Abciximab, Troponin release

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Catheterization immediate PCI

Arm Title

Arm Type

Experimental

Arm Description

delayed PCI

Intervention Type

Procedure

Intervention Name(s)

Catheterization immediate PCI

Intervention Description

Catheterization immediate PCI

Intervention Type

Procedure

Intervention Name(s)

delayed PCI

Intervention Description

delayed PCI

Primary Outcome Measure Information:

Title

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

Time Frame

during the hospital phase

Secondary Outcome Measure Information:

Title

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

Time Frame

during 1month following randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilles MONTALESCOT, Professor

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut de Cardiologie - Hôpital Pitié-Salpétrière

City

Paris

ZIP/Postal Code

75013

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

22795712

Citation

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.

Results Reference

derived

PubMed Identifier

19724041

Citation

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.

Results Reference

derived

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

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