Local Thrombolytics Before Thrombectomy in STEMI (DISSOLUTION)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Urokinase
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring thrombectomy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Urokinase
Saline
Arm Description
Patients will be randomized to to receive local bolus of 200,000 units urokinase
Patients will be randomized to to receive local bolus of intracoronary saline
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Myocardial reperfusion after Primary CI
ST-segment resolution (STR)>70% as assessed 90 minutes after Primary PCI
Left ventricular remodeling
A change in left ventricular end-diastolic volume>20% (compared with baseline values) as assessed at 1-year echocardiography
5-year MACE
Death, reinfarction, new-onset severe heart failure, and rehospitalization for heart failure
Full Information
NCT ID
NCT01568931
First Posted
March 29, 2012
Last Updated
April 6, 2020
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT01568931
Brief Title
Local Thrombolytics Before Thrombectomy in STEMI
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
thrombectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Urokinase
Arm Type
Active Comparator
Arm Description
Patients will be randomized to to receive local bolus of 200,000 units urokinase
Arm Title
Saline
Arm Type
Active Comparator
Arm Description
Patients will be randomized to to receive local bolus of intracoronary saline
Intervention Type
Drug
Intervention Name(s)
Urokinase
Other Intervention Name(s)
UROKINASE-R, IMARX THERAPEUTICS INC., Tucson, AZ
Intervention Description
intracoronary, urokinase, 200,000 Units, bolus
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Saline infusion
Intervention Description
intracoronary, saline, bolus 1 cc
Primary Outcome Measure Information:
Title
Outcomes at 30 days
Description
30-day occurrence of death, new Q-wave myocardial infarction, coronary artery bypass grafting, target lesion revascularization, stroke, or stent thrombosis
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Myocardial reperfusion after Primary CI
Description
ST-segment resolution (STR)>70% as assessed 90 minutes after Primary PCI
Time Frame
Up to 90 minutes after Primary PCI
Title
Left ventricular remodeling
Description
A change in left ventricular end-diastolic volume>20% (compared with baseline values) as assessed at 1-year echocardiography
Time Frame
Up to 1 year after Primary PCI
Title
5-year MACE
Description
Death, reinfarction, new-onset severe heart failure, and rehospitalization for heart failure
Time Frame
Up to 5 years after Primary PCI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesare Greco, MD
Organizational Affiliation
University Sapienza
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Local Thrombolytics Before Thrombectomy in STEMI
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