Local Thrombolytics Before Thrombectomy in STEMI (DISSOLUTION)
This study is not yet open for participant recruitment.
Verified March 2013 by University of Roma La Sapienza
Sponsor:
University of Roma La Sapienza
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01568931
First received: March 29, 2012
Last updated: March 6, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: Urokinase Drug: Saline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Local Delivery of thrombolytIcs Before Thrombectomy in patientS With ST-elevatiOn myocardiaL Infarction Undergoing Primary percuTaneous Coronary interventION - The DISSOLUTION Randomized Trial |
Resource links provided by NLM:
Further study details as provided by University of Roma La Sapienza:
Primary Outcome Measures:
- MACE at 30 days [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]30-day Major adverse cardiac events (MACE), defined as the 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 [ Time Frame: Up to 90 minutes after Primary PCI ] [ Designated as safety issue: No ]ST-segment resolution (STR)>70% as assessed 90 minutes after Primary PCI
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2014 |
| Estimated Study Completion Date: | March 2017 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Saline infusion
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568931
Contacts
| Contact: Gaetano Tanzilli, MD | +39064997 ext 262 | gaetano.tanzilli@uniroma1.it |
| Contact: Francesco Pelliccia, MD | +39064997 ext 262 | f.pelliccia@mclink.it |
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
| Study Director: | Cesare Greco, MD | University Sapienza |
More Information
No publications provided
| Responsible Party: | Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza |
| ClinicalTrials.gov Identifier: | NCT01568931 History of Changes |
| Other Study ID Numbers: | 197/2012/D |
| Study First Received: | March 29, 2012 |
| Last Updated: | March 6, 2013 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by University of Roma La Sapienza:
|
thrombectomy |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Myocardial Infarction Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013