Local Thrombolytics Before Thrombectomy in STEMI (DISSOLUTION)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by University of Roma La Sapienza
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 September 16, 2014