Local Thrombolytics Before Thrombectomy in STEMI (DISSOLUTION)

April 6, 2020 updated by: Francesco Pelliccia, University of Roma La Sapienza

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Urokinase
Patients will be randomized to to receive local bolus of 200,000 units urokinase
Drug: Urokinase
intracoronary, urokinase, 200,000 Units, bolus
Other Names:
  • UROKINASE-R, IMARX THERAPEUTICS INC., Tucson, AZ
ACTIVE_COMPARATOR: Saline
Patients will be randomized to to receive local bolus of intracoronary saline
Drug: Saline
intracoronary, saline, bolus 1 cc
Other Names:
  • Saline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcomes at 30 days
Time Frame: Up to 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial reperfusion after Primary CI
Time Frame: Up to 90 minutes after Primary PCI
ST-segment resolution (STR)>70% as assessed 90 minutes after Primary PCI
Up to 90 minutes after Primary PCI
Left ventricular remodeling
Time Frame: Up to 1 year after Primary PCI
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
5-year MACE
Time Frame: Up to 5 years after Primary PCI
Death, reinfarction, new-onset severe heart failure, and rehospitalization for heart failure
Up to 5 years after Primary PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (ESTIMATE)

April 2, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 197/2012/D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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