Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction

Phase 4

Completed

• Conditions: STEMI - ST Elevation Myocardial Infarction
• Interventions: Drug: Unfractionated heparin

• Registration Number: NCT05247424
• Lead Sponsor: University Medical Centre Ljubljana

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-01-30
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-18
• Study Start: 2022-03-10
• Primary Completion: 2025-02-05
• Study Completion: 2025-03-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Adult patients with STEMI referred for primary PCI
• Duration of symptoms less than 6 hours before presentation

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early unfractionated heparin	Unfractionated heparin	Administration of UFH at a dose of 100 IU/kg body weight at first medical contact. Addition of UFH before coronary intervention according to ACT measurement after coronary angiography before coronary intervention.

Primary Outcome Measures

Name	Time	Method
TIMI flow	Day 0	TIMI flow in culprit coronary artery at first coronary angiography

Secondary Outcome Measures

Name	Time	Method
Bleeding	Day 0	Bleeding assessed by Bleeding Academic Research Consortium (BARC) score. BARC incorporates 5 bleeding types, ranging from BARC 0 - no bleeding to BARC 5 - fatal bleeding.
Troponin I concentration 24 h after primary PCI	24 h	Troponin I concentration 24 h after primary PCI
Cardiogenic shock	Day 0 to 10	Presence of cardiogenic shock at any time after randomization
30 day mortality after STEMI	30 days	30-day mortality after STEMI

Trial Locations

Locations (1)

UMC Ljubljana; 🇸🇮 Ljubljana, Slovenia