Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction

Last updated: April 28, 2025
Sponsor: University Medical Centre Ljubljana
Overall Status: Completed

Phase

4

Condition

Coronary Artery Disease

Hypercholesterolemia

Congestive Heart Failure

Treatment

Unfractionated heparin

Clinical Study ID

NCT05247424
Heparin-STEMI
  • Ages > 18
  • All Genders

Study Summary

Rupture of a coronary artery plaque leads to thrombotic occlusion of the coronary artery and would present as ST segment elevation myocardial infarction. Early treatment with aspirin and early primary percutaneous coronary intervention are indicated. Anticoagulation therapy, usually with unfractionated heparin, is required during percutaneous coronary intervention.

Investigators hypothesis is that pretreatment with unfractionated heparin in addition to aspirin at first medical contact may facilitate spontaneous reperfusion of culprit artery and procedural thrombotic complication in patients with ST elevation myocardial infarction without significant risk of bleeding complications.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients with STEMI referred for primary PCI

  • Duration of symptoms less than 6 hours before presentation

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Cardiogenic shock at presentation (hemodynamic instability)

  • Cardiac arrest before randomization

  • Duration of symptoms for more than 6 hours before presentation

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Unfractionated heparin
Phase: 4
Study Start date:
March 10, 2022
Estimated Completion Date:
March 05, 2025

Study Description

Randomization of patients with STEMI at first medical contact in a 1:1 ratio into an intervention group receiving 100 IU of unfractionated heparin (UFH) per kilogram of body weight IV and later additionally UFH after diagnostic coronary angiography according to the activated clotting time (ACT) and a control group receiving only UFH after diagnostic coronary angiography at the dose of 100 IU per kilogram of body weight.

The primary end point of the study is TIMI flow at coronary angiography. Secondary endpoints are: Bleeding complications (defined by BARC score), occurrence of cardiogenic shock, and 30-day mortality.

Investigators plan to randomize 600 patients.

Connect with a study center

  • UMC Ljubljana

    Ljubljana, 1000
    Slovenia

    Site Not Available

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