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THE REOPEN-AMI STUDY - Intracoronary Nitroprusside Versus Adenosine in Acute Myocardial Infarction

NCT00590070 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2012-03-27

No results posted yet for this study

Summary

The occurrence of no-reflow phenomenon after recanalization of the infarct related artery in acute myocardial infarction is described in up to 40% of cases. This event is associated with a worse prognosis at follow up and an unfavourable left ventricular remodelling . Two main pathogenetic mechanisms cause no-reflow: distal embolization and ischemia-reperfusion injury.

Due to the multifactorial pathogenesis of no-reflow during acute MI a combined mechanic and pharmacologic approach is believed to offer a better solution for achieving optimal microvascular reperfusion. Thus, in this randomized study we will assess the effect of nitroprusside or adenosine in adjunct to current best therapy (thrombus aspiration and IIb-IIIa antagonists) for ST elevation MI using ST segment resolution on standard 12 leads ECG as primary endpoint of myocardial reperfusion.

Conditions

Interventions

DRUG

adenosine

Adenosine (80 mcg as fast bolus followed by 2 mg given in 33cc of saline in 2 minutes as slow bolus)

DRUG

nitroprusside

Nitroprusside (60 mcg as fast bolus followed by 100 mcg given in 33cc of 5% glucose in 2 minutes as slow bolus)

DRUG

placebo

33 cc of heparinized saline given in 2 minutes as slow bolus

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Giampaolo Niccoli, MD, PhD · Institute of Cardiology UCSC

  • Filippo Crea, MD · Institute of Cardiology UCSC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-06-30
Completion
2011-09-30

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00590070 on ClinicalTrials.gov