Local Thrombolytics Before Thrombectomy in STEMI

Coronary Artery Disease Clinical Trial

— DISSOLUTION  

Official title:

Local Delivery of thrombolytIcs Before Thrombectomy in patientS With ST-elevatiOn myocardiaL Infarction Undergoing Primary percuTaneous Coronary interventION - The DISSOLUTION Randomized Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01568931
• Other study ID #: 197/2012/D
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: March 2021

Study information

• Verified date: April 2020
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: March 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• Urokinase
intracoronary, urokinase, 200,000 Units, bolus
• Saline
intracoronary, saline, bolus 1 cc

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcomes at 30 days	30-day occurrence of death, new Q-wave myocardial infarction, coronary artery bypass grafting, target lesion revascularization, stroke, or stent thrombosis	Up to 30 days
Secondary	Myocardial reperfusion after Primary CI	ST-segment resolution (STR)>70% as assessed 90 minutes after Primary PCI	Up to 90 minutes after Primary PCI
Secondary	Left ventricular remodeling	A change in left ventricular end-diastolic volume>20% (compared with baseline values) as assessed at 1-year echocardiography	Up to 1 year after Primary PCI
Secondary	5-year MACE	Death, reinfarction, new-onset severe heart failure, and rehospitalization for heart failure	Up to 5 years after Primary PCI