Local Thrombolytics Before Thrombectomy in STEMI (DISSOLUTION)

University of Roma La Sapienza

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Urokinase; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01568931

197/2012/D

Details and patient eligibility

About

Background Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of ST-elevation myocardial infarction (STEMI) improves clinical outcomes through salvage of myocardial tissue.

Although the use of thrombus aspiration with PCI can result in improved rates of normal epicardial flow and myocardial perfusion, several unmet needs remain.

Purpose The purpose of this trial will be to evaluate the hypothesis that local delivery of thrombolytics vs. saline infusion prior to thrombus aspiration and PCI is safe and effective in patients with STEMI.

Full description

The study will select patients with ST-elevation myocardial infarction (STEMI) with angiographic evidence of massive thrombosis in the culprit artery undergoing manual thrombectomy followed by primary percutaneous coronary intervention (PCI).

Patients will be randomized to receive local bolus of 200,000 units urokinase or saline solution

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ST-elevation myocardial infarction
• angiographic evidence of massive thrombosis in the culprit artery
• Indication to manual thrombectomy followed by primary percutaneous coronary intervention (PCI)
• Able to understand and willing to sign the informed CF

Exclusion criteria

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Urokinase

Active Comparator group

Description:

Patients will be randomized to to receive local bolus of 200,000 units urokinase

Treatment:

Drug: Urokinase

Saline

Active Comparator group

Description:

Patients will be randomized to to receive local bolus of intracoronary saline

Treatment:

Drug: Saline