STEMI - ST Elevation Myocardial InfarctionPhase 4UFH-STEMINCT05247424
Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction
A Phase 4 study testing Unfractionated heparin in people with STEMI - ST Elevation Myocardial Infarction, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Unfractionated heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSlovenia
- Study dates
- 10 Mar 2022to 5 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with STEMI referred for primary PCI
- Duration of symptoms less than 6 hours before presentation
Who cannot join
- Pregnancy
- Cardiogenic shock at presentation (hemodynamic instability)
- Cardiac arrest before randomization
- Duration of symptoms for more than 6 hours before presentation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Unfractionated heparin
- Keywords
- Myocardial Reperfusion, Unfractionated heparin, pre-treatment
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unfractionated heparinDrug
Unfractionated heparin at dose of 100 IU /kg body weight
| Study group | Role | What they receive |
|---|---|---|
| Early unfractionated heparin | Experimental | 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. Receives: Drug: Unfractionated heparin |
| Control - Unfractionated heparin for coronary intervention only | No intervention | Control arm with administration of UFH at a dose of 100 IU/kg body weight after coronary angiography before coronary intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIMI flow
TIMI flow in culprit coronary artery at first coronary angiography
Measured: Day 0
Secondary outcomes (4)
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.
Measured: Day 0
Cardiogenic shock
Presence of cardiogenic shock at any time after randomization
Measured: Day 0 to 10
30 day mortality after STEMI
30-day mortality after STEMI
Measured: 30 days
Troponin I concentration 24 h after primary PCI
Troponin I concentration 24 h after primary PCI
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start10 Mar 2022
- Primary completion5 Feb 2025
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomization in 1:1 ratio
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Radsel, University Medical Centre Ljubljana
- Investigators
- Miša Fister, MD, PhD, Study chair, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247424
- Sponsor's protocol ID
- Heparin-STEMI
- Acronym
- UFH-STEMI
- Status last verified
- Apr 2025
- First submitted
- 30 Jan 2022
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fister M, Noc M, Radsel P, Bunc M, Franco D, Goslar T; HEPARIN-STEMI Trial. Prehospital Heparin Administration in Patients With STEMI Undergoing Primary PCI: HEPARIN-STEMI Randomized Controlled Trial. Circulation. 2026 May 19;153(20):1526-1534. doi: 10.1161/CIRCULATIONAHA.126.079839. Epub 2026 Mar 30.
PubMed 41910504
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05247424
- Acronym / sponsor ID
- UFH-STEMI / Heparin-STEMI
- Keywords
- Myocardial Reperfusion, Unfractionated heparin, pre-treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomization in 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Early unfractionated heparin | Experimental | Drug: Unfractionated heparinAdministration 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. |
| Control - Unfractionated heparin for coronary intervention only | No intervention | –Control arm with administration of UFH at a dose of 100 IU/kg body weight after coronary angiography before coronary intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with STEMI referred for primary PCI
- Duration of symptoms less than 6 hours before presentation
Key exclusion criteria (4 listed)
- Pregnancy
- Cardiogenic shock at presentation (hemodynamic instability)
- Cardiac arrest before randomization
- Duration of symptoms for more than 6 hours before presentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unfractionated heparinUnfractionated heparin at dose of 100 IU /kg body weight | Drug | Early unfractionated heparin |
Primary outcome
TIMI flow
Time frame: Day 0
TIMI flow in culprit coronary artery at first coronary angiography
4 secondary outcomes
Bleeding
Time frame: Day 0
Cardiogenic shock
Time frame: Day 0 to 10
30 day mortality after STEMI
Time frame: 30 days
Troponin I concentration 24 h after primary PCI
Time frame: 24 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Derived from this study: PubMed 41910504Fister M, Noc M, Radsel P, Bunc M, Franco D, Goslar T; HEPARIN-STEMI Trial. Prehospital Heparin Administration in Patients With STEMI Undergoing Primary PCI: HEPARIN-STEMI Randomized Controlled Trial. Circulation. 2026 May 19;153(20):1526-1534. doi: 10.1161/CIRCULATIONAHA.126.079839. Epub 2026 Mar 30.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miša Fister, MD, PhD study chair
UMC Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Unfractionated heparin in people with STEMI - ST Elevation Myocardial Infarction, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIMI flow (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05247424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.