Randomized Evaluation of Beta Blocker and ACEI/ARB Treatment in MINOCA Patients - MINOCA-BAT (MINOCA-BAT)
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| ClinicalTrials.gov Identifier: NCT03686696 |
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Recruitment Status :
Recruiting
First Posted : September 27, 2018
Last Update Posted : September 8, 2021
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Myocardial infarction with non-obstructive coronary arteries" (MINOCA) occurs in 5-10% of all patients with AMI. There are neither any randomized clinical trials in MINOCA patients evaluating effects of secondary preventive treatments proven beneficial in patients with classic AMI, nor any treatment guidelines.
The primary objective of this multi-national, multi-center pragmatic randomized clinical trial is to determine whether oral beta-blockade compared to no oral beta-blockade, and whether Angiotensin Converting Enzyme Inhibitors (ACEI/ Angiotensin Receptor Blockers (ARB) compared to no ACEI/ARB, reduce the composite endpoint of death of any cause and readmission because of AMI, ischemic stroke or heart failure in patients discharged with myocardial infarction with non-obstructive coronary artery disease (MINOCA) and with no clinical signs of heart failure and with left ventricular (LV) systolic ejection fraction ≥40%.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myocardial Infarction With Non-obstructive Coronary Arteries | Drug: Beta blocker Drug: ACEI Drug: ARB | Phase 4 |
Large-scale use of acute coronary angiography has revealed a large portion of AMI without angiographically obstructive (defined as ≥50% diameter stenosis) coronary artery disease (CAD). The term "myocardial infarction with non-obstructive coronary arteries" (MINOCA) has been coined for this entity. MINOCA occurs in 5-10% of all patients with AMI and these patients are younger and more often females compared to patients with AMI and obstructive CAD. The 1-year mortality after MINOCA was found to be 3.5% in the systematic review by Pasupathy et al.. There are no randomized clinical trials in MINOCA patients evaluating effects of secondary preventive treatments proven beneficial in patients with classic AMI. However, in an observational study with propensity score matched comparisons the risk of experiencing a Major Adverse Cardiac Event (MACE) was 18% lower in patients treated with ACEI/ARB compared to no ACEI/ARB; in patients on beta blockers compared to patients not using beta blockers there was a non-significant 14% reduction in MACE.
The primary objective of this multi-national, multi-center pragmatic randomized clinical trial is to determine whether oral beta-blockade compared to no oral beta-blockade, and whether ACEI/ARB compared to no ACEI/ARB, reduce the composite endpoint of death of any cause and readmission because of AMI, ischemic stroke or heart failure in patients discharged with myocardial infarction with non-obstructive coronary artery disease (MINOCA) and with no clinical signs of heart failure and with LV systolic ejection fraction ≥40%.
PRIMARY ENDPOINT: Time to death of any cause or readmission because of myocardial infarction, ischemic stroke or heart failure.
SECONDARY ENDPOINTS:
Time to:
- All-cause mortality
- Cardiovascular mortality
- Readmission because of AMI
- Readmission because of ischemic stroke
- Readmission because of heart failure
- Readmission because of unstable angina pectoris
- Readmission because of atrial fibrillation.
Safety:
Time to readmission because of:
- AV-block II-III, hypotension, syncope or need for pacemaker
- Acute kidney injury
- Ventricular tachycardia/fibrillation
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 3500 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Intervention Model Description: | 2 * 2 Factorial Design |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Evaluation of Beta Blocker and Angiotensin Converting Enzyme Inhibitor (ACEI) /Angiotensin Receptor Blocker (ARB) Treatment in MINOCA Patients. |
| Actual Study Start Date : | December 16, 2018 |
| Estimated Primary Completion Date : | July 31, 2026 |
| Estimated Study Completion Date : | November 30, 2026 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: No Beta blocker and no ACEI/ARB
No Beta blocker and no ACEI/ARB
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Experimental: Beta blocker and ACEI/ARB
Beta blocker and either ACE inhibitor or Angiotensin receptor blocker
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Drug: Beta blocker
Patients randomized to beta-blockade will be administered the assigned treatment during the rest of the hospital stay and receive a prescription for the continued use at discharge. The treating physician is encouraged to aim for target dose or highest tolerable dose for the drug. Patients will be encouraged to continue the use of the randomized treatment following discharge until contraindications.
Other Name: Beta receptor blocker Drug: ACEI Patients randomized to ACE inhibitor will be administered the assigned treatment during the rest of the hospital stay and receive a prescription for the continued use at discharge. The treating physician is encouraged to aim for target dose or highest tolerable dose for the drug. Patients will be encouraged to continue the use of the randomized treatment following discharge until contraindications.
Other Name: ACE inhibitor Drug: ARB Patients randomized to Angiotensin receptor blockers will be administered the assigned treatment during the rest of the hospital stay and receive a prescription for the continued use at discharge. The treating physician is encouraged to aim for target dose or highest tolerable dose for the drug. Patients will be encouraged to continue the use of the randomized treatment following discharge until contraindications
Other Name: Angiotensin receptor blocker |
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Experimental: Beta blocker alone
Beta blocker alone
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Drug: Beta blocker
Patients randomized to beta-blockade will be administered the assigned treatment during the rest of the hospital stay and receive a prescription for the continued use at discharge. The treating physician is encouraged to aim for target dose or highest tolerable dose for the drug. Patients will be encouraged to continue the use of the randomized treatment following discharge until contraindications.
Other Name: Beta receptor blocker |
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Experimental: ACEI/ARB alone
Either ACE inhibitor or Angiotensin receptor blocker alone
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Drug: ACEI
Patients randomized to ACE inhibitor will be administered the assigned treatment during the rest of the hospital stay and receive a prescription for the continued use at discharge. The treating physician is encouraged to aim for target dose or highest tolerable dose for the drug. Patients will be encouraged to continue the use of the randomized treatment following discharge until contraindications.
Other Name: ACE inhibitor Drug: ARB Patients randomized to Angiotensin receptor blockers will be administered the assigned treatment during the rest of the hospital stay and receive a prescription for the continued use at discharge. The treating physician is encouraged to aim for target dose or highest tolerable dose for the drug. Patients will be encouraged to continue the use of the randomized treatment following discharge until contraindications
Other Name: Angiotensin receptor blocker |
- Time to death of any cause, or time to readmission because of AMI, ischemic stroke or heart failure [ Time Frame: Time to event from the date of enrollment through study completion, an average of 4 years. ]A Composite of time to all-cause Death and time to re-admission because of AMI, ischemic stroke or heart failure
- a All-cause death b Cardiovascular death c Readmission because of AMI d Readmission because of ischemic stroke e Readmission because of heart failure f Readmission because of unstable angina pectoris g Readmission because of atrial fibrillation. [ Time Frame: a All-cause death: Time to event from the date of enrollment through study completion, an average of 4 years. ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >18 years.
- A clinical diagnosis of MINOCA within the last 30 days.
- Left ventricular ejection fraction ≥40% measured with echocardiography, MRI or left ventriculography after admission and prior to randomization.
- Written informed consent obtained
Exclusion Criteria:
- Any condition that may influence the patient's ability to comply with study protocol.
- Previous revascularization (CABG or PCI)
- Clinical signs of heart failure
- MRI-proven myocarditis or a strong clinical suspicion of myocarditis or takotsubo as cause of the index event
- Contraindications for Beta blocker treatment
- Contraindications for ACEI and ARB treatment
- Prior use of ACEI, ARB, or Beta blockers, which must continue according to treating physician.
- New indication for Beta blocker or ACEI/ARB treatment other than as secondary prevention according to treating physician
- Ongoing pregnancy or woman of childbearing potential not using adequate contraceptives
- Participation in a trial evaluating a drug known to interact with Beta blockers or ACEI/ARB
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686696
| Contact: Isabelle Lilja, MSc Pharm | +46 18 611 03 33 | isabelle.lilja@ucr.uu.se |
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| Study Chair: | Bertil Lindahl, Prof | Uppsala University |
| Responsible Party: | Uppsala University |
| ClinicalTrials.gov Identifier: | NCT03686696 |
| Other Study ID Numbers: |
EudraCT number 2018-000889-11 |
| First Posted: | September 27, 2018 Key Record Dates |
| Last Update Posted: | September 8, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | We will make a limited, de-identified set of data available for researchers outside the primary investigators two years after the publication of the primary results of the study. Before data are shared, a data-sharing agreement should be established documenting what data are being shared and how the data can be used. The agreement serves two purposes. First, it protects the agency providing the data, ensuring that the data will not be misused. Second, it prevents miscommunication on the part of the provider of the data and the agency receiving the data by making certain that any questions about data use are discussed. The following items should be covered in the data-sharing agreement:
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| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Myocardial infarction Treatment ACE inhibitors Angiotensin receptor blockade Beta blockers |
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Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Adrenergic beta-Antagonists |
Angiotensin-Converting Enzyme Inhibitors Angiotensin Receptor Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Protease Inhibitors Enzyme Inhibitors |