Local Thrombolytics Before Thrombectomy in STEMI

NCT01568931 | Unknown Phase 4

• 1 other identifier: 197/2012/D
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Keywords

thrombectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Myocardial reperfusion after Primary CI

  Up to 90 minutes after Primary PCI

• Left ventricular remodeling

  Up to 1 year after Primary PCI

• 5-year MACE

  Up to 5 years after Primary PCI

Study Arms (2)

Urokinase

ACTIVE COMPARATOR

Patients will be randomized to to receive local bolus of 200,000 units urokinase

Drug: Urokinase

Saline

ACTIVE COMPARATOR

Patients will be randomized to to receive local bolus of intracoronary saline

Drug: Saline

Interventions

Urokinase DRUG

intracoronary, urokinase, 200,000 Units, bolus

Also known as: UROKINASE-R, IMARX THERAPEUTICS INC., Tucson, AZ

Urokinase

Saline DRUG

intracoronary, saline, bolus 1 cc

Also known as: Saline infusion

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Urokinase-Type Plasminogen Activator; Sodium Chloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Cesare Greco, MD

  University Sapienza

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: January 1, 2014
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2021
• Last Updated: April 8, 2020

Record last verified: 2020-04