NCT03686696

Brief Summary

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%.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2018

Longer than P75 for phase_4

Geographic Reach
5 countries

32 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 16, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2023

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

4.5 years

First QC Date

September 3, 2018

Last Update Submit

November 21, 2023

Conditions

Myocardial Infarction With Non-obstructive Coronary Arteries

Keywords

Myocardial infarctionTreatmentACE inhibitorsAngiotensin receptor blockadeBeta blockers

Outcome Measures

Primary Outcomes (1)

  • Time to death of any cause, or time to readmission because of AMI, ischemic stroke or heart failure

    A Composite of time to all-cause Death and time to re-admission because of AMI, ischemic stroke or heart failure

    Time to event from the date of enrollment through study completion, an average of 4 years.

Secondary Outcomes (1)

  • 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.

    a All-cause death: Time to event from the date of enrollment through study completion, an average of 4 years.

Study Arms (4)

No Beta blocker and no ACEI/ARB

NO INTERVENTION

No Beta blocker and no ACEI/ARB

Beta blocker and ACEI/ARB

EXPERIMENTAL

Beta blocker and either ACE inhibitor or Angiotensin receptor blocker

Drug: Beta blockerDrug: ACEIDrug: ARB

Beta blocker alone

EXPERIMENTAL

Beta blocker alone

Drug: Beta blocker

ACEI/ARB alone

EXPERIMENTAL

Either ACE inhibitor or Angiotensin receptor blocker alone

Drug: ACEIDrug: ARB

Interventions

Beta blockerDRUG

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.

Also known as: Beta receptor blocker
Beta blocker aloneBeta blocker and ACEI/ARB
ACEIDRUG

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.

Also known as: ACE inhibitor
ACEI/ARB aloneBeta blocker and ACEI/ARB
ARBDRUG

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

Also known as: Angiotensin receptor blocker
ACEI/ARB aloneBeta blocker and ACEI/ARB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Royal Adelaide Hospital

Adelaide, Sout Australi, Australia

Location

The Lyell McEwin Hospital

Adelaide, Australia

Location

The Queen Elizabeth Hospital

Adelaide, Australia

Location

Gold Coast Hospital

Gold Coast, Australia

Location

Sunshine Hospital

Melbourne, Australia

Location

Royal Perth Hospital

Perth, Australia

Location

Gosford Hospital

Sydney, Australia

Location

John Hunter Hospital

Sydney, Australia

Location

Auckland University Hospital

Auckland, New Zealand

Location

Haukeland University Hospital

Bergen, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Getafe University Hospital

Getafe, Spain

Location

C.H.U. Ourense

Ourense, Spain

Location

C.H. Universitario de Santiago

Santiago de Compostela, Spain

Location

Mälardalens sjukhus Eskilstuna

Eskilstuna, Sweden

Location

Falu Lasarett

Falun, Sweden

Location

Gävle sjukhus

Gävle, Sweden

Location

Sahlgrenska Universitetssjukhus, Sahlgrenska

Gothenburg, Sweden

Location

Hallands sjukhus

Halmstad, Sweden

Location

Helsingborg Lasarett

Helsingborg, Sweden

Location

Ryhovs sjukhus

Jönköping, Sweden

Location

Centralsjukhuset Karlstad

Karlstad, Sweden

Location

Västmanlands sjukhus Köping

Köping, Sweden

Location

Universitetssjukhuset i Linköping

Linköping, Sweden

Location

Skånes Universitetssjukhus Lund

Lund, Sweden

Location

Skånes universtitetssjukhus Malmö

Malmo, Sweden

Location

Vrinneviesjukhuset

Norrköping, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Danderyd Hospital

Stockholm, Sweden

Location

Söderskjukhuset

Stockholm, Sweden

Location

Akademiska Sjukhuset

Uppsala, Sweden

Location

Västerås Lasarett

Västerås, Sweden

Location

Related Publications (1)

  • Nordenskjold AM, Agewall S, Atar D, Baron T, Beltrame J, Bergstrom O, Erlinge D, Gale CP, Lopez-Pais J, Jernberg T, Johansson P, Ravn-Fisher A, Reynolds HR, Somaratne JB, Tornvall P, Lindahl B. Randomized evaluation of beta blocker and ACE-inhibitor/angiotensin receptor blocker treatment in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA-BAT): Rationale and design. Am Heart J. 2021 Jan;231:96-104. doi: 10.1016/j.ahj.2020.10.059. Epub 2020 Oct 24.

    PMID: 33203618DERIVED

MeSH Terms

Conditions

MINOCAMyocardial Infarction

Interventions

Adrenergic beta-AntagonistsAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor Antagonists

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Adrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of DrugsProtease InhibitorsEnzyme Inhibitors

Study Officials

  • Bertil Lindahl, Prof

    Uppsala University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 2 \* 2 Factorial Design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2018

First Posted

September 27, 2018

Study Start

December 16, 2018

Primary Completion

May 31, 2023

Study Completion

August 22, 2023

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

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: * Period of agreement * Intended use of the data * Constraints on use of the data * Data confidentiality * Data security * Methods of data-sharing

Shared Documents
STUDY PROTOCOL, SAP

Locations

NO(2)ES(3)NZ(1)SE(18)AU(8)