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Randomized Evaluation of Intracoronary nitroprusside vs adenosine after thrombus aspiration during primary PErcutaneous coronary intervention for the prevention of No reflow in Acute Myocardial Infarction: REOPEN -AMI study - REOPEN -AMI

Randomized Evaluation of Intracoronary nitroprusside vs adenosine after thrombus aspiration during primary PErcutaneous coronary intervention for the prevention of No reflow in Acute Myocardial Infarction: REOPEN -AMI study - REOPEN -AMI

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-006794-93-IT
Enrollment
240
Registered
2007-12-10
Start date
2008-09-02
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myocardial infarction with ST segment elevation MedDRA version: 6.1 Level: PT Classification code 10000891

Interventions

Trade Name: KRENOSIN*EV 6F 2ML 6MG/2ML Pharmaceutical Form: Solution for injection INN or Proposed INN: Adenosine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6-

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Symptoms onset =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. age less than 18 years 2. previous STEMI 3. patients presenting in cardiogenic shock 4. pregnancy 5. patients with renal failure 6. contraindications to contrast agents, which cannot be managed medically or study mediactions, including aspirin, clopidogrel and ticlopidine, and heparin Electrocardiogram 7. left bundle branch block, paced rhythm, frequent ventricular ectopy, pre-excitation or other conditions or artifacts interfering with interpretation of ST segment resolution Angiography 8. culprit lesion located in a by-pass graft 9. stent thrombosis 10. culprit lesion non identified 11. left main disease

Design outcomes

Primary

MeasureTime frame
Main Objective: Aim of this randomized study is to assess the effect of nitroprusside or adenosine in adjunct to current best therapy (thrombus aspiration and IIb-IIIa antagonists) for ST elevation MI;Secondary Objective: 1) rate of angiographic no-reflow; 2) changes of LV volumes at follow-up; 3) rate of no-reflow on IC ECG; 4) rate of no-reflow at echocontrastography; 5) rate of MACEs;Primary end point(s): Primary end-point of the study will be rate of ST resolution on surface ECG.

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026