A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI (EASY-MI)

Laval University

Status and phase: Completed; Phase 4

Conditions: Ischemia; Myocardial Infarction

Treatments: Drug: Abciximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00440778

EASY-MI

Details and patient eligibility

About

HYPOTHESES

1. Bolus administration of total abciximab dose provides superior maximal and mean platelet aggregation inhibition (PAI) compared with standard bolus (0.25 mg/kg) administration.
2. Total dose of abciximab can be given as a single bolus and is more effective than bolus (0.25 mg/kg) + 12 hrs infusion in terms of acute and mid-term angiographic and clinical results.
3. Intracoronary (ic) abciximab administration is more effective than intravenous (iv) route of administration in terms of acute and mid-term angiographic and clinical results.
4. There is a relationship between PAI and angiographic perfusion scores.
5. Routine use of sirolimus-eluting stents (Cypher, Cordis) in primary-PCI is associated with a low rate of target vessel revascularization and complications.
6. Cardiac MRI early and late after primary-PCI provides detailed information on myocardial injury and irreversible necrosis, which are correlated with angiographic perfusion scores.
7. After uncomplicated trans-radial PCI, patients can be retransferred early to their referring center.

Full description

OBJECTIVES AND END-POINTS The objectives of the present study are to assess the benefits and safety of 1) a single bolus of abciximab (100% dose) compared with the standard bolus (ca 80% of the total dose) + 12h infusion (ca 20% of the total dose), and 2) intracoronary abciximab bolus administration compared with intravenous route of abciximab administration in primary PCI.

The primary PLATELETS end-points are the percentage of patients with ≥ 95% platelet aggregation inhibition 10 minutes after abciximab bolus (MAX) and the mean platelet aggregation inhibition 10 minutes after abciximab bolus (MEAN).

The secondary CLINICAL end-points of the study are:

• The composite of death, stroke, repeat myocardial infarction, urgent target vessel revascularization and major bleedings at 30 days following primary PCI.
• The composite of cardiovascular death, repeat myocardial infarction and repeat target vessel revascularization at 6-months follow-up.

The secondary ANGIOGRAPHIC end-points of the study are:

• The proportion of patients having myocardial blush grade 2-3 and TIMI 3 score at the end of PCI in the culprit vessel.
• The restenosis rate (diameter stenosis ≥ 50%) and late loss in the culprit vessel at 6-months follow-up.

Other exploratory end-points are the feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, the cardiac MRI measurements and platelet aggregation inhibition at 6h post-PCI.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with acute myocardial infarction eligible for primary PCI within 6 h of symptoms: patient must have prolonged, continuous (lasting at least 20 minutes) signs and symptoms of ischemia not eliminated with nitrates and onset within 6 h of randomization, and one of the following:

  • ST-segment elevation ≥ 2 mm in 2 or more contiguous precordial ECG leads (anterior infarction)
  • ST-segment depression ≥ 2 mm in V1, V2 or V2, V3 with reciprocal 1 mm ST-elevation in II, augmented unipolar foot (left leg) lead (AVF), and V6 (true posterior infarction)
  • ST-segment elevation ≥ 1 mm in 2 or more contiguous limb ECG leads (other infarction)
  • New or presumably new left bundle branch block (LBBB)

• Patient must be > 18 years of age.

• 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 trans-radial/ulnar artery approach.

• The culprit lesion can be identified on a native coronary vessel, which is suitable for primary PCI with stent implantation.

Exclusion criteria

• Patient has received thrombolytic therapy (within the last 4 weeks) and is referred for rescue PCI
• Concurrent participation in other investigational study
• Femoral sheath (artery)
• Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for at least 12 months
• Any significant blood dyscrasia, diathesis or INR > 2.0
• Any clinical contraindication to abciximab (ReoPro®) administration i.e. known structural intracranial lesion, thrombocytopenia < 100,000, active or recent bleeding or hemoglobin level known < 10 g/dl.
• Any glycoprotein IIb-IIIa inhibitors use in the previous 30 days
• 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
• Infarction caused by in-stent thrombosis or restenosis
• Cardiogenic shock evident before randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 4 patient groups

Gr 1 - intracoronary + infusion

Experimental group

Description:

abciximab bolus 0.25 mg/kg ic + 12 hrs iv infusion

Treatment:

Drug: Abciximab

Gr 2 - intracoronary

Experimental group

Description:

100% abciximab bolus dose 0.3 mg/kg ic

Treatment:

Drug: Abciximab

Gr 3 - intravenous

Active Comparator group

Description:

abciximab bolus dose 0.25 mg/kg iv + 12 hrs iv infusion

Treatment:

Drug: Abciximab

Gr 4 - intravenous

Experimental group

Description:

100% abciximab bolus dose 0.3 mg/kg iv

Treatment:

Drug: Abciximab