Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction

Conditions
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STEMI - ST Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Unfractionated heparin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomization in 1:1 ratio
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early unfractionated heparin<br>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. | Drug: Unfractionated heparin<br>* Unfractionated heparin at dose of 100 IU /kg body weight<br>|
| No Intervention: Control - Unfractionated heparin for coronary intervention only<br>Control arm with administration of UFH at a dose of 100 IU/kg body weight after coronary angiography before coronary intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIMI flow | TIMI flow in culprit coronary artery at first coronary angiography | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | 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. | Day 0 | 
| Cardiogenic shock | Presence of cardiogenic shock at any time after randomization | Day 0 to 10 | 
| 30 day mortality after STEMI | 30-day mortality after STEMI | 30 days | 
| Troponin I concentration 24 h after primary PCI | Troponin I concentration 24 h after primary PCI | 24 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-treatment, Myocardial Reperfusion, Unfractionated heparin