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

NCT00440778 | Completed Phase 4 DMC

• 1 other identifier: EASY-MI
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

HYPOTHESES

1. 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. 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. 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. 4.There is a relationship between PAI and angiographic perfusion scores.
5. 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. 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. 7.After uncomplicated trans-radial PCI, patients can be retransferred early to their referring center.

Conditions

Myocardial Infarction; Ischemia

Keywords

Coronary artery stenting; Trans-radial; Intracoronary

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with at least 95% platelet aggregation inhibition, and mean platelet aggregation inhibition.

  10 min after bolus of abciximab

Secondary Outcomes (5)

• Composite of death, stroke, repeat MI, urgent target vessel revascularization and major bleedings at 30 days following primary PCI.

  30 days

• Composite of cardiovascular death, repeat MI and repeat target vessel revascularization at 6-month follow-up.

  6 months

• Proportion of patients having myocardial blush grade 2-3 and TIMI 3 score at the end of PCI in the culprit vessel.

  At end of PCI

• Restenosis rate (diameter stenosis equal or higher than 50%) and late loss in the culprit vessel at 6-month follow-up.

  6 months

• Exploratory end-points: feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, cardiac MRI measurements and platelet aggregation inhibition at 6hr post-PCI.

  At 6hr post-PCI

Study Arms (4)

Gr 1 - intracoronary + infusion

EXPERIMENTAL

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

Drug: Abciximab

Gr 2 - intracoronary

EXPERIMENTAL

100% abciximab bolus dose 0.3 mg/kg ic

Drug: Abciximab

Gr 3 - intravenous

ACTIVE COMPARATOR

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

Drug: Abciximab

Gr 4 - intravenous

EXPERIMENTAL

100% abciximab bolus dose 0.3 mg/kg iv

Drug: Abciximab

Interventions

Abciximab DRUG

100% abciximab bolus dose (0.3 mg/kg) ic or iv vs standard bolus (0.25 mg/kg) ic or iv plus 12-hr infusion

Also known as: Abciximab (ReoPro)

Gr 1 - intracoronary + infusion; Gr 2 - intracoronary; Gr 3 - intravenous; Gr 4 - intravenous

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Eli Lilly and Company: collaborator
• Cordis US Corp.: collaborator
• Quebec Heart Institute: collaborator

Study Sites (1)

Laval Hospital

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

• Bertrand OF, Larose E, Costerousse O, Mongrain R, Rodes-Cabau J, Dery JP, Nguyen CM, Barbeau G, Gleeton O, Proulx G, De Larochelliere R, Noel B, Roy L. Effects of aspiration thrombectomy on necrosis size and ejection fraction after transradial percutaneous coronary intervention in acute ST-elevation myocardial infarction. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):475-82. doi: 10.1002/ccd.22692.

  PMID: 20578162 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Ischemia

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Olivier F Bertrand, MD, PhD

  Laval Hospital Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 27, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 24, 2011

Record last verified: 2011-11

Locations

CA (1)