Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction (UFH-STEMI)

University Medical Centre Ljubljana

Status and phase: Completed; Phase 4

Conditions: STEMI - ST Elevation Myocardial Infarction

Treatments: Drug: Unfractionated heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT05247424

Heparin-STEMI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

Early unfractionated heparin

Experimental group

Description:

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.

Treatment:

Drug: Unfractionated heparin

Control - Unfractionated heparin for coronary intervention only

No Intervention group

Description:

Control arm with administration of UFH at a dose of 100 IU/kg body weight after coronary angiography before coronary intervention.