Acute Myocardial InfarctionPhase 4REVERSE-FLOWNCT02739711
Glycoprotein IIb/IIIa Inhibitors Versus Standard Therapy in Patients with Myocardial Infarction and No-reflow
A Phase 4 study testing Glycoprotein IIb/IIIa inhibitors in people with Acute Myocardial Infarction, run by University of Luebeck at 1 site in Germany.
Trial summary
Aim of the study is to examine the effects of glycoprotein IIb/IIIa inhibitors on reperfusion success assessed by cardiac magnetic resonance imaging in patients with myocardial infarction and angiographic evidence of no-reflow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Glycoprotein IIb/IIIa inhibitors
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2016to Dec 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
- ST-elevation myocardial infarction and non-ST-elevation myocardial infarction <48 h after symptom onset
- Angiographic evidence of no-reflow (Thrombolysis in Myocardial Infarction-flow grade ≤2) after primary percutaneous coronary intervention
- Age ≥18 years
- Informed consent
Who cannot join
- ST-elevation myocardial infarction and non-ST-elevation myocardial infarction patients with Thrombolysis in Myocardial Infarction-flow 3 after primary percutaneous coronary intervention
- Age ≤18 years
- Known pregnancy, breast-feeding or intend to become pregnant during the study period
- Contraindication for treatment with platelet inhibitors
- Known allergy to glycoprotein IIb/IIIa inhibitors, aspirin, or heparin
- Active peptic gastric or duodenal ulcer
Show all 20Show fewer
- History of major surgery (including intracranial or intraspinal) <4 weeks
- Active bleeding or bleeding diathesis
- Stroke <2 years (ischemic and hemorrhagic)
- Known coagulation defect or relevant thrombocytopenia
- Arteriovenous malformations or aneurysm
- Severe liver insufficiency
- Renal insufficiency requiring dialysis
- Uncontrolled hypertension
- Hypertensive retinopathy
- Vasculitis
- Fibrinolysis <12 hours
- Contraindication for cardiac magnetic resonance imaging at study entry
- Patients without informed consent
- Participation in another trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective RandomizEd Study Comparing Glycoprotein IIb/IIIa Inhibitors VERsus Standard Therapy in PatientS with Myocardial Infarction and Angiographic Evidence of No-reFLOW
Aim of the study is to examine the effects of glycoprotein IIb/IIIa inhibitors on reperfusion success assessed by cardiac magnetic resonance imaging in patients with myocardial infarction and angiographic evidence of no-reflow.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Glycoprotein IIb/IIIa inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycoprotein IIb/IIIa inhibitorsDrug
Glycoprotein IIb/IIIa inhibitors intravenous bolus followed by an intravenous infusion for 12/18 h plus medical standard therapy
| Study group | Role | What they receive |
|---|---|---|
| Glycoprotein IIb/IIIa inhibitor | Active comparator | Glycoprotein IIb/IIIa inhibitor administration Receives: Drug: Glycoprotein IIb/IIIa inhibitors |
| Standard therapy | No intervention | No glycoprotein IIb/IIIa inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size assessed by cardiac magnetic resonance imaging
Measured: Day 1-10 after myocardial infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2024
- Study completionDec 2025 (estimated)
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 Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Ingo Eitel, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739711
- Sponsor's protocol ID
- AZ 15-259
- Acronym
- REVERSE-FLOW
- Status last verified
- May 2024
- First submitted
- 13 Apr 2016
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Eitel I, Saraei R, Jurczyk D, Fach A, Hambrecht R, Wienbergen H, Frerker C, Schmidt T, Allali A, Joost A, Marquetand C, Kurz T, Haaf P, Fahrni G, Mueller C, Desch S, Thiele H, Stiermaier T. Glycoprotein IIb/IIIa inhibitors in acute myocardial infarction and angiographic microvascular obstruction: the REVERSE-FLOW trial. Eur Heart J. 2024 Dec 16;45(47):5058-5067. doi: 10.1093/eurheartj/ehae587.
PubMed 39217605
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective RandomizEd Study Comparing Glycoprotein IIb/IIIa Inhibitors VERsus Standard Therapy in PatientS with Myocardial Infarction and Angiographic Evidence of No-reFLOW
- ClinicalTrials.gov ID
- NCT02739711
- Acronym / sponsor ID
- REVERSE-FLOW / AZ 15-259
- Conditions
- Acute Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- May 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Apr 2016 (estimated)
- 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.
Aim of the study is to examine the effects of glycoprotein IIb/IIIa inhibitors on reperfusion success assessed by cardiac magnetic resonance imaging in patients with myocardial infarction and angiographic evidence of no-reflow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glycoprotein IIb/IIIa inhibitor | Active comparator | Drug: Glycoprotein IIb/IIIa inhibitorsGlycoprotein IIb/IIIa inhibitor administration |
| Standard therapy | No intervention | –No glycoprotein IIb/IIIa inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ST-elevation myocardial infarction and non-ST-elevation myocardial infarction <48 h after symptom onset
- Angiographic evidence of no-reflow (Thrombolysis in Myocardial Infarction-flow grade ≤2) after primary percutaneous coronary intervention
- Age ≥18 years
- Informed consent
Key exclusion criteria (20 listed)
- ST-elevation myocardial infarction and non-ST-elevation myocardial infarction patients with Thrombolysis in Myocardial Infarction-flow 3 after primary percutaneous coronary intervention
- Age ≤18 years
- Known pregnancy, breast-feeding or intend to become pregnant during the study period
- Contraindication for treatment with platelet inhibitors
- Known allergy to glycoprotein IIb/IIIa inhibitors, aspirin, or heparin
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 |
|---|---|---|
| Glycoprotein IIb/IIIa inhibitorsGlycoprotein IIb/IIIa inhibitors intravenous bolus followed by an intravenous infusion for 12/18 h plus medical standard therapy | Drug | Glycoprotein IIb/IIIa inhibitor |
Primary outcome
Infarct size assessed by cardiac magnetic resonance imaging
Time frame: Day 1-10 after myocardial infarction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Derived from this study: PubMed 39217605Eitel I, Saraei R, Jurczyk D, Fach A, Hambrecht R, Wienbergen H, Frerker C, Schmidt T, Allali A, Joost A, Marquetand C, Kurz T, Haaf P, Fahrni G, Mueller C, Desch S, Thiele H, Stiermaier T. Glycoprotein IIb/IIIa inhibitors in acute myocardial infarction and angiographic microvascular obstruction: the REVERSE-FLOW trial. Eur Heart J. 2024 Dec 16;45(47):5058-5067. doi: 10.1093/eurheartj/ehae587.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Glycoprotein IIb/IIIa inhibitors in people with Acute Myocardial Infarction, run by University of Luebeck at 1 site in Germany.
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 4 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 3 Jan 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 Germany. 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?
Results are not available in the source record.
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?
Infarct size assessed by cardiac magnetic resonance imaging (time frame: Day 1-10 after myocardial infarction). 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 NCT02739711, 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 3 Jan 2025.