A Randomized Trial of Early Discharge After Trans-Radial Stenting of Coronary Arteries in Acute MI and Rescue-PCI

Condition(s) targeted: Myocardial Infarction; Ischemia

Intervention: Abciximab (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Laval University

Official(s) and/or principal investigator(s):
Olivier F Bertrand, MD, PhD, Principal Investigator, Affiliation: Laval Hospital Research Center

Overall contact:
Olivier F Bertrand, MD, PhD, Phone: +1 418 656 8711, Email: olivier.bertrand@crhl.ulaval.ca

- Abciximab administration is safe and reduces ischemic complications in patients

undergoing rescue PCI after failed thrombolysis compared to placebo.

- Abciximab improves angiographic scores and ventricular function after rescue-PCI

compared to placebo.

- Intracoronary abciximab administration is more effective than intravenous route of

administration in terms of acute and mid-term angiographic and clinical results.

- Intracoronary and intravenous bolus administration of abciximab dose provides similar

platelet aggregation inhibition (PAI).

- There is a significant relationship between PAI after abciximab administration and

indexes of myocardial perfusion.

- Routine use of Sirolimus-eluting stents (Cypher, Cordis, US) in rescue-PCI is

associated with a low rate of target vessel revascularization.

- Cardiac MRI early and late after rescue-PCI provides detailed information on myocardial

injury and irreversible necrosis, which are correlated with angiographic perfusion scores.

- After uncomplicated trans-radial rescue PCI, patients can be retransferred early to

their referring center.

Official title: A Randomized Trial of Early Discharge After Trans-Radial Stenting of Coronary Arteries in Acute Myocardial Infarction and RESCUE-PCI: The EASY-RESCUE Pilot Study

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: TIMI score and myocardial blush grade after rescue-PCI at baseline and at 6-month follow-up

Secondary outcome:

1 Composite of death, stroke, repeat-MI, urgent target vessel revascularization and major bleedings at 30 days after rescue PCI

2 Composite of death, repeat-MI, repeat target vessel revascularization at 6 months following rescue PCI

3 Proportion of patients with platelet aggregation inhibition ≥ 95% and mean platelet aggregation inhibition 10 min post-bolus administration

4 Angiographic late loss and restenosis rate (diameter stenosis ≥ 50%) in the culprit artery

5 Exploratory end-points include the feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, cardiac MRI measurements and PAI 6 h after bolus administration

Detailed description: OBJECTIVES AND END-POINTS

The objectives of the present pilot study are to assess 1) the benefits and safety of abciximab i. c. or i. v. compared to placebo in rescue PCI and trans-radial approach, 2) the relationship between platelet aggregation inhibition and perfusion scores and to demonstrate 3) better perfusion scores with i. c. abciximab as compared to i. v. abciximab or placebo.

The Primary ANGIOGRAPHIC end-point will be the TIMI score and myocardial blush grade after rescue-PCI at baseline and at 6-months follow-up.

The Secondary CLINICAL end-point will be:

- the composite of death, stroke, repeat-myocardial infarction, urgent target vessel

revascularization and major bleedings at 30 days after rescue PCI.

- composite of death, repeat-myocardial infarction, repeat target vessel

revascularization at 6 months following rescue PCI.

The Secondary PLATELETS end-point will be the proportion of patients with platelet aggregation inhibition ≥ 95% and mean platelet aggregation inhibition 10 minutes post-bolus administration.

The Secondary ANGIOGRAPHIC end-points will be the angiographic late loss and the restenosis rate (Diameter stenosis ≥ 50%) in the culprit artery.

Other exploratory end-points include the feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, cardiac MRI measurements and PAI 6 hr after bolus administration.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient with acute myocardial infarction eligible for rescue PCI within 24 hrs of

symptoms.

- Failed thrombolysis (defined as less than 50% reduction of ST-elevation at 90 min ECG

in the lead with previous maximal ST-segment elevation).

- Patient > 18 years old.

- Patient and treating interventional cardiologist agree for randomization.

- Patient will be informed of the randomization process and will sign an informed

consent.

- Diagnostic and therapeutic intervention performed through transradial/transulnar

approach.

- The culprit lesion in a native coronary artery can identified and is suitable for

immediate angioplasty and stent implantation.

Exclusion Criteria:

- Age > 75 years old

- Body weight < 65 kg

- Concurrent participation in other investigational study

- Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for 12

months

- Any significant blood dyscrasia, diathesis or INR > 2. 0.

- Any clinical contraindication to abciximab administration i. e. known structural

intracranial lesion, thrombocytopenia (< 100,000), hemoglobin level < 10 g/dl

- Patient has received more than one dose of thrombolytic within 24 hours of symptoms

- Previous treatment with glycoproteins IIb-IIIa inhibitors within 30 days

- Perceived increased risk of intracranial or severe bleeding i. e. previous stroke/TIA,

alteration of consciousness, recent trauma or major surgery.

- Uncontrolled high blood pressure i. e. systolic blood pressure ≥ 180 mmHg and/or

diastolic blood pressure ≥ 100 mmHg.

- Life expectancy less than 6 months owing to non-cardiac cause

- Evident cardiogenic shock

Olivier F Bertrand, MD, PhD, Phone: +1 418 656 8711, Email: olivier.bertrand@crhl.ulaval.ca

Laval Hospital, Quebec G1V 4G5, Canada; Recruiting
Olivier F Bertrand, MD, PhD, Phone: +1 418 656 8711, Email: olivier.bertrand@crhl.ulaval.ca
Michele Jadin, MSc, Phone: +1 418 656 8711, Email: michele.jadin@crhl.ulaval.ca
Olivier F Bertrand, MD, PhD, Principal Investigator
Eric Larose, MD, DVM, Sub-Investigator
Josep Rodes-Cabau, MD, Sub-Investigator

Starting date: February 2007
Ending date: September 2009
Last updated: October 9, 2008