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Myocardial Infarction Type 2NCT06736353

Effect of Classic Secondary Prevention in Type 2 MI: A Target Trial Emulation Study

An observational study of Myocardial Infarction Type 2, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A classic heart attack is caused by a blockage to the coronary arteries that supplies the heart muscle with oxygenated blood. The medical term for this condition is type 1 myocardial infarction. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction Type 2
How many people
14,000 participants
Where
1 siteSweden
Study dates
3 Sep 2010to 5 May 2022
How long will I take part?
6 Years
Phase
Observational
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

Study population: All patients reported as type 2 myocardial infarction (first reporting) in the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART). SWEDEHEART is a Swedish national register for coronary artery disease care and valvular interventions. All Swedish hospitals report to SWEDEHEART. Reported myocardial infarction patients have been classified into type 1-5 since 2010 by the reporting physician. All patients will be included, from the first reporting, until the date of data collection.

Who may be able to join

  • Reported as Type 2 MI in SWEDEHEART
  • Age >18 years
  • Alive at time zero (hospital discharge)
  • Reported as Type 2 MI in SWEDEHEART
  • Age >18 years
  • Alive at time zero (hospital discharge)
Show all 15Show fewer
  • Reported as Type 2 MI in SWEDEHEART
  • Age >18 years
  • Alive at time zero (hospital discharge)
  • Reported as Type 2 MI in SWEDEHEART
  • Age >18 years
  • Alive at time zero (hospital discharge)
  • Reported as Type 2 MI in SWEDEHEART
  • Age >18 years
  • Alive at time zero (hospital discharge)

Who cannot join

  • Already on beta blocker
  • Heart failure with reduced ejection fraction
  • Hypertrophic obstructive cardiomyopathy
  • Systolic blood pressure <90 mmHg
  • Heart rate <50 bpm
  • Metastatic cancer (proxy for terminal disease)
Show all 60Show fewer
  • History of dementia or substance abuse last 6 months (proxy for unable to adhere to treatment)
  • Missing data for any exclusion criteria
  • RAAS blocker target trial emulation:
  • Already on RAAS blocker
  • Heart failure with reduced ejection fraction
  • Combination of prior myocardial infarction and diabetes mellitus
  • Diabetic nephropathy,
  • Systolic blood pressure <90 mmHg
  • Hyperkalemia
  • Acute renal failure
  • Pregnancy
  • Metastatic cancer (proxy for terminal disease)
  • History of dementia or substance abuse last 6 months (proxy for unable to adhere to treatment)
  • Missing data for any exclusion criteria
  • Statin target trial emulation:
  • Already on Statin
  • Revascularization during hospitalization
  • Obstructive coronary artery disease detected during hospitalization
  • History of myocardial infarction or coronary revascularization
  • History of stroke
  • History of peripheral artery disease
  • Familial hypercholesterolemia
  • Pregnancy
  • Acute or chronic liver failure
  • Metastatic cancer (proxy for terminal disease)
  • History of dementia or substance abuse last 6 months (proxy for unable to adhere to treatment)
  • Missing data for any exclusion criteria
  • Single Antiplatelet Therapy target trial emulation:
  • Already on antiplatelet therapy
  • Revascularization during hospitalization
  • Obstructive coronary artery disease detected during hospitalization
  • Indication for dual antiplatelet therapy according to treating physician
  • History of myocardial infarction or coronary revascularization
  • History of stroke
  • History of peripheral artery disease
  • Severe anemia (Hemoglobin <90g/L)
  • Intracranial or gastrointestinal bleeding within the last 12 months
  • Bleeding disorder
  • Acute bleeding during hospitalization
  • Metastatic cancer (proxy for terminal disease)
  • History of dementia or substance abuse last 6 months (proxy for unable to adhere to treatment)
  • Missing data for any exclusion criteria
  • Dual Antiplatelet Therapy target trial emulation:
  • Already on Dual Antiplatelet Therapy
  • Revascularization during hospitalization
  • Severe anemia (Hemoglobin <90g/L)
  • Pregnancy
  • Treatment with oral anticoagulants
  • Intracranial or gastrointestinal bleeding within the last 12 months
  • Bleeding disorder
  • Acute bleeding during hospitalization
  • Metastatic cancer (proxy for terminal disease)
  • History of dementia or substance abuse last 6 months (proxy for unable to adhere to treatment)
  • Missing data for any exclusion criteria

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Department of medical sciences, Uppsala University

    Uppsala, 751 05

Other trials in Sweden

About this study

A classic heart attack is caused by a blockage to the coronary arteries that supplies the heart muscle with oxygenated blood. The medical term for this condition is type 1 myocardial infarction. There is strong scientific evidence that the usage of pharmacological drugs such as statins, beta blockers, Renin-Angiotensin-Aldosterone System blockers and platelet inhibitors after a type 1 myocardial infarction improves survival and reduces the risk for new myocardial infarctions. However, a myocardial infarction may also occur without blockage to the coronary arteries when other acute conditions causes either a decreased supply or an increased demand of oxygenated blood to the heart. The medical term for the latter is type 2 myocardial infarction. There are currently no scientific evidence that any pharmacological drug improves survival in patients with a type 2 myocardial infarction, of whom only one in three patients are alive after five years.

The aim of this study is to investigate if those drugs that improves the prognosis after a type 1 myocardial infarction (Beta blockers, Renin-Angiotensin-Aldosterone System blockers, Statins and platelet inhibitors) also affects the prognosis after a type 2 myocardial infarction.

Read more

The best way to answer this question would be to conduct clinical trials for each drug where type 2 myocardial infarction patients are randomized to either receiving the drug of interest or receiving placebo (sugar pills) and then compare the survival and outcomes in both groups over time.

However, clinical trials are costly, time consuming and also difficult to conduct with type 2 myocardial infarction patients since these patients are treated at various hospital departments.

Therefore, this study will instead include patients in a Swedish national register for myocardial infarction, in which myocardial infarction patients are reported from all Swedish hospitals, and compare type 2 myocardial infarction patients that did receive or did not receive each treatment. To minimize the risk of making inaccurate conclusions about the causal relationship between treatment and outcome, the study will define the optimal clinical trial for each treatment and then specifically emulate these trials in all possible aspects using the register data. This method is called "target trial emulation".

Read the detailed description

While acute and long term treatments in type 1 myocardial infarction (MI) are well documented, there are no evidence based treatments altering the prognosis in type 2 MI patients, of whom only one in three are alive after five years. Classic secondary preventive treatment in type 1 MI include the use of statins, beta blockers, renin-angiotensin-aldosterone system (RAAS) inhibitors, single antiplatelet therapy (SAPT) and dual antiplatelet therapy (DAPT). While some observational studies suggest classic secondary preventive MI treatment to be associated with better survival in type 2 MI, others do not.

The aim of this study is to investigate if there is an association between treatment with each of statins, beta blockers, RAAS inhibitors, SAPT or DAPT; and all-cause mortality or long-term cardiovascular events in patients with type 2 MI.

The study will be conducted as (several) registry-based observational studies emulating pre-specified target trials. A protocol of a pragmatic randomized controlled trial (a target trial) will be specified for each of statins, beta blockers, RAAS inhibitors, SAPT and DAPT; including eligibility criteria, treatment assignment, time zero and follow up, outcomes, causal contrast and statistical analyses.

Each of these components will then be emulated using registry data. The target trial, as well as the registry-based study emulating the target trial, will differ slightly for each treatment.

The study will include all, approximately 14 000, patients reported as type 2 MI (first reporting for each patient) in the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) from 2010 and onward. Data from SWEDEHEART will be merged with data from the National Patient Register, the Swedish Cause of Death Register and the Longitudinal Integrated Database for Health Insurance and Labour Market Studies.

Patients will be followed from hospital discharge (time zero) until death, loss to follow-up or end of follow up (date of data collection). Treatment specific eligibility criteria will be applied at time zero. All important confounding factors at time zero will be identified by drawing causal diagrams, one for each treatment and outcome. Treatment specific models with registry data will then be created to balance the assigned groups using for example inverse probability weighting with multiple imputation of missing data among covariates.

For all target trial emulations, the primary outcome of interest will be a composite endpoint of all-cause mortality, readmission for MI, stroke or heart failure. Secondary outcomes will be all-cause mortality, cardiovascular mortality, readmission for MI, readmission for stroke and readmission for heart failure individually. Safety outcomes will be specified separately for each treatment. Readmission for bacterial pneumonia will be used as a negative control outcome in all target trial emulations to check for residual confounding. Intention-to-treat analysis will be performed for each treatment and outcome. Competing risk methodology will be applied as appropriate.

Being tested
Beta Blocker Therapy or No Therapy (Control), RAAS blocker Therapy or No therapy (Control), Statin Therapy or No Therapy (Control), Single Antiplatelet Therapy or No Therapy (Control), Dual Antiplatelet Therapy or No Therapy (Control)
Keywords
Target trial emulation, Beta blocker, Statin, RAAS blocker, Single antiplatelet therapy, Dual antiplatelet therapy, Type 2 myocardial infarction, SWEDEHEART

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beta Blocker Therapy or No Therapy (Control)Drug

    Beta blocker therapy or no Beta blocker therapy initiated after type 2 myocardial infarction

  • RAAS blocker Therapy or No therapy (Control)Drug

    RAAS blocker therapy or no RAAS blocker therapy initiated after type 2 myocardial infarction

  • Statin Therapy or No Therapy (Control)Drug

    Statin therapy or no Statin therapy initiated after type 2 myocardial infarction

  • Single Antiplatelet Therapy or No Therapy (Control)Drug

    Single Antiplatelet Therapy or no antiplatelet therapy initiated after type 2 myocardial infarction

  • Dual Antiplatelet Therapy or No Therapy (Control)Drug

    Dual Antiplatelet Therapy or no Dual Antiplatelet Therapy initiated after type 2 myocardial infarction

Study groups in NCT06736353
Study groupRoleWhat they receive
Type 2 myocardial infarctionAll patients reported as type 2 myocardial infarction (first reporting) in the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART)
Receives: Drug: Beta Blocker Therapy or No Therapy (Control); Drug: RAAS blocker Therapy or No therapy (Control); Drug: Statin Therapy or No Therapy (Control); Drug: Single Antiplatelet Therapy or No Therapy (Control); Drug: Dual Antiplatelet Therapy or No Therapy (Control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite

    Composite endpoint: All-cause mortality, readmission for MI, stroke or heart failure

    Measured: From enrollment (hospital discharge after type 2 MI) until Composite endpoint, Loss to follow-up or End of follow up (date of data collection: 05-May-2022)

Secondary outcomes (5)
  1. All-cause mortality

    Death from any cause

    Measured: From enrollment (hospital discharge after type 2 MI) until Death, Loss to follow-up or End of follow up (date of data collection: 05-May-2022)

  2. Cardiovascular mortality

    Death from cardiovascular disease

    Measured: From enrollment (hospital discharge after type 2 MI) until Cardiovascular death, Loss to follow-up or End of follow up (date of data collection: 05-May-2022). Competing risk methodology applied.

  3. Readmission for MI

    Readmission for myocardial infarction

    Measured: From enrollment (hospital discharge after type 2 MI) until Readmission for MI, Loss to follow-up or End of follow up (date of data collection: 05-May-2022). Competing risk methodology applied.

  4. Readmission for stroke

    Readmission for stroke

    Measured: From enrollment (hospital discharge after type 2 MI) until Readmission for Stroke, Loss to follow-up or End of follow up (date of data collection: 05-May-2022). Competing risk methodology applied.

  5. Readmission for heart failure

    Readmission for heart failure

    Measured: From enrollment (hospital discharge after type 2 MI) until Readmission for Heart failure, Loss to follow-up or End of follow up (date of data collection: 05-May-2022). Competing risk methodology applied.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2024
  2. Study start3 Sep 2010
  3. Primary completion5 May 2022
  4. Study completion5 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
14,000 participants (actual)
Target duration
6 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06736353
Sponsor's protocol ID
TYPE2_MI_TARGET_TRIALS
Other IDs
KF10-0024
Status last verified
Mar 2025
First submitted
11 Dec 2024
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Due to Swedish laws on personal integrity and health data, as well as the Ethics Committee, we are not allowed to make any data included health variables open to the public even if made anonymous. The data could be shared with other researchers after a request to the head of our department

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction Type 2, run by Uppsala University at 1 site in Sweden.

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 15 inclusion and 60 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 19 Mar 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 Sweden. 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.

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?

Composite (time frame: From enrollment (hospital discharge after type 2 MI) until Composite endpoint, Loss to follow-up or End of follow up (date of data collection: 05-May-2022)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 19 Mar 2025.

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