Clinical Trials Logo

Clinical Trial Summary

In this study the investigators test the hypothesis that alteplase given intra coronary after PCI reduce infarct size in patients with ST-elevation myocardial infarction(STEMI) and impaired microvascular function defined as a value of index of microvascular resistance (IMR) >30.

Clinical Trial Description

After coronary stenting, index of microvascular resistance (IMR) will be measured invasively. Patients with IMR >30 will be randomised to 20 mg alteplase or placebo (NaCl) administered in the culprit vessel through a microcatheter. Magnet resonance imaging (MRI) of the myocardium will be performed early (2-6 days) and late (3 months) to estimate the primary endpoint (infarct size).

10 non-randomised patients, with IMR <30, will undergo the same follow-up as the randomised patients.

Clinical events for all randomised and non-randomised patients will be collected from Swedish national registries and by telephone at 3 and 12 months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

NCT number NCT02894138
Study type Interventional
Source Vastra Gotaland Region
Contact Oskar Angerås, MD, PhD
Phone +46703134091
Status Recruiting
Phase Phase 3
Start date September 2016
Completion date December 2017

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02641262 - Henan STEMI Registry
Completed NCT01826552 - Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent Phase 4
Recruiting NCT01738100 - Ticagrelor and Intracoronary Morphine in Patients Undergoing Primary Percutaneous Coronary Intervention Phase 2
Recruiting NCT03671603 - Post-Marketing Safety Study in ST-Segment Elevation Myocardial Infarction (STEMI) Participants Undergoing Primary Percutaneous Coronary Intervention (PCI) Procedure With VISIPAQUE® as the Contrast Medium
Recruiting NCT02606435 - Thrombus Aspiration in Patients With STEMI Phase 4
Completed NCT01203982 - Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima-media Thickness (CIMT) Phase 4
Active, not recruiting NCT03338309 - INsTantenous wavE-Free Ratio-guided PCI Versus Fractional Flow REserve-Guided PCI in rouTine Clinical Practice, Prospective, Multicenter Registry
Recruiting NCT02445885 - Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction Phase 2/Phase 3
Recruiting NCT03371784 - The Effect of Glucocorticoid Therapy on Left Ventricular Remodelling in Acute Myocardial Infarction (RECONSIDER) Phase 2/Phase 3
Completed NCT03389503 - Comparison of Left and Right Transradial Approach for CAG and PCI N/A
Completed NCT02311231 - Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART Phase 4
Completed NCT02324348 - Efficacy and Safety Study of Deferred Stenting in Patients With STEMI N/A
Completed NCT01385631 - Ezetimibe In Addition To Atorvastatin Therapy On The Plaque Composition In Patients With Acute Myocardial Infarction. Phase 4
Completed NCT03690713 - International Collaboration of Comprehensive Physiologic Assessment
Enrolling by invitation NCT02670005 - Fractional Flow Reserve Versus Angiography for Guiding Selective Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction N/A
Completed NCT02164695 - Remote Ischemic Perconditioning in Patients With ST-segment Elevation Myocardial Infarction N/A
Active, not recruiting NCT02070471 - Phase 2 Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients Phase 2
Terminated NCT02075125 - Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction Phase 3
Completed NCT01510171 - Rapid Activity of Platelet Inhibitor Drugs Study Phase 4
Completed NCT01384019 - Distal Protection Device in ST-elevation Myocardial Infarction (STEMI) Phase 4