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

NCT00590070 | Completed Phase 2 DMC

• 2 other identifiers: REOPEN-AMI 2007-006794-932007-006794-93
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Myocardial Infarction

Keywords

myocardial infarction; no reflow; primary PCI; Coronary no-reflow phenomenon; primary percutaneous coronary intervention (primary PCI)

Outcome Measures

Primary Outcomes (1)

• Rate of major adverse cardiac events

  6 months

Study Arms (3)

1

ACTIVE COMPARATOR

Patients will receive intravenous administration of abciximab prior to PCI. After wire crossing, thrombus aspiration will be performed. The device will removed outside the body, flushed with saline and subsequently reintroduced in the culprit vessel beyond the occlusion site and intracoronary drugs will be selectively administered.

Drug: adenosine

2

ACTIVE COMPARATOR

Patients will receive intravenous administration of abciximab prior to PCI. After wire crossing, thrombus aspiration will be performed. The device will removed outside the body, flushed with saline and subsequently reintroduced in the culprit vessel beyond the occlusion site and intracoronary drugs will be selectively administered.

Drug: nitroprusside

3

PLACEBO COMPARATOR

Patients will receive intravenous administration of abciximab prior to PCI. After wire crossing, thrombus aspiration will be performed. The device will removed outside the body, flushed with saline and subsequently reintroduced in the culprit vessel beyond the occlusion site and intracoronary drugs will be selectively administered

Drug: placebo

Interventions

adenosine DRUG

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

1

nitroprusside DRUG

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

2

placebo DRUG

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

3

Eligibility Criteria

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

You may qualify if:

• Symptoms onset \< 12 hours prior to enrollment
• ST-segment elevation of at least 2 mm in two or more contiguous leads
• TIMI flow 0-1 at baseline angiography

You may not qualify if:

• Demographic, history and clinical examination
• age less than 18 years
• previous STEMI
• patients presenting in cardiogenic shock
• pregnancy
• patients with renal failure
• contraindications to contrast agents, which cannot be managed medically or study medications, including aspirin, clopidogrel and ticlopidine, and heparin
• Electrocardiogram
• left bundle branch block, paced rhythm, frequent ventricular ectopy, pre-excitation or other conditions or artifacts interfering with interpretation of ST segment resolution Angiography
• culprit lesion located in a by-pass graft
• stent thrombosis
• culprit lesion non identified
• left main disease

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Dipartimento Medicina Cardiovascolare

Rome, Rome, 00100, Italy

Location

Related Publications (25)

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MeSH Terms

Conditions

Myocardial Infarction

Interventions

Adenosine; Nitroprusside

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ferricyanides; Cyanides; Anions; Ions; Electrolytes; Inorganic Chemicals; Ferric Compounds; Iron Compounds; Hydrogen Cyanide; Nitrogen Compounds

Study Officials

• Giampaolo Niccoli, MD, PhD

  Institute of Cardiology UCSC

  PRINCIPAL INVESTIGATOR

• Filippo Crea, MD

  Institute of Cardiology UCSC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dott. Prof.

Study Record Dates

• First Submitted: December 31, 2007
• First Posted: January 10, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 27, 2012

Record last verified: 2012-03

Locations

IT (1)