Completed

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

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What is being tested

Abciximab

Drug
Who is being recruted

Cardiovascular Diseases+7

+ Heart Diseases

+ Infarction

From 18 to 75 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: February 2007
See protocol details

Summary

Principal SponsorOlivier F. Bertrand
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2007

Actual date on which the first participant was enrolled.

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.

Official TitleA Randomized Trial of Early Discharge After Trans-Radial Stenting of Coronary Arteries in Acute Myocardial Infarction and RESCUE-PCI: The EASY-RESCUE Pilot Study
NCT00440895
Principal SponsorOlivier F. Bertrand
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

74 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesInfarctionIschemiaMyocardial InfarctionNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial Ischemia

Criteria

7 inclusion criteria required to participate
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.

Show More Criteria

12 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Bolus abciximab i.c. (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min).

Group II

Active Comparator
Bolus abciximab i.v. (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min).

Group III

Placebo
Bolus of placebo followed by 12 h infusion (placebo).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Laval Hospital

Québec, CanadaOpen Laval Hospital in Google Maps
CompletedOne Study Center