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

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05247424

Collaborator

(none)

600

Enrollment

Arms

19.4

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
STEMI - ST Elevation Myocardial Infarction	Drug: Unfractionated heparin	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomization in 1:1 ratiorandomization in 1:1 ratio

Masking:

Single (Outcomes Assessor)

Masking Description:

Interventional cardiologists evaluating coronary angiography will be blinded to assigned group

Primary Purpose:

Treatment

Official Title:

Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction

Anticipated Study Start Date :

Feb 15, 2022

Anticipated Primary Completion Date :

May 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Early 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.

Drug: Unfractionated heparin

Unfractionated heparin at dose of 100 IU /kg body weight

No Intervention: Control - Unfractionated heparin for coronary intervention only

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

Outcome Measures

Primary Outcome Measures

TIMI flow [Day 0]
TIMI flow in culprit coronary artery at first coronary angiography

Secondary Outcome Measures

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.
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
Troponin I concentration 24 h after primary PCI [24 h]
Troponin I concentration 24 h after primary PCI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Medical Centre Ljubljana

Investigators

Study Chair: Miša Fister, MD, PhD, UMC Ljubljana

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peter Radsel, Head of intensive internal medicine department, University Medical Centre Ljubljana

ClinicalTrials.gov Identifier:

NCT05247424

Other Study ID Numbers:

Heparin-STEMI

First Posted:

Feb 18, 2022

Last Update Posted:

Feb 18, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peter Radsel, Head of intensive internal medicine department, University Medical Centre Ljubljana

Myocardial Reperfusion

Unfractionated heparin

pre-treatment

Additional relevant MeSH terms:

Myocardial Infarction

ST Elevation Myocardial Infarction

Infarction

Heparin

Calcium heparin

Study Results

No Results Posted as of Feb 18, 2022