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

NCT06736353 | Completed FDA Drug

• 2 other identifiers: TYPE2_MI_TARGET_TRIALSKF10-0024
• Study Type: observational
• Target: 14,000
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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".

Conditions

Myocardial Infarction Type 2

Keywords

Target trial emulation; Beta blocker; Statin; RAAS blocker; Single antiplatelet therapy; Dual antiplatelet therapy; Type 2 myocardial infarction; SWEDEHEART

Outcome Measures

Primary Outcomes (1)

• Composite

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

  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)

• All-cause mortality

  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)

• Cardiovascular mortality

  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.

• Readmission for MI

  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.

• Readmission for stroke

  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.

• Readmission for heart failure

  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.

Other Outcomes (5)

• Readmission for Asthma or COPD

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

• Readmission for Acute renal failure

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

• Readmission for bleeding

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

Study Arms (1)

Type 2 myocardial infarction

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)

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)

Interventions

Beta Blocker Therapy or No Therapy (Control) DRUG

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

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

Type 2 myocardial infarction

Statin Therapy or No Therapy (Control) DRUG

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

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

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

Type 2 myocardial infarction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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)
• History of dementia or substance abuse last 6 months (proxy for unable to adhere to treatment)
• RAAS blocker target trial emulation:
• Reported as Type 2 MI in SWEDEHEART
• Age \>18 years
• Alive at time zero (hospital discharge)
• Already on RAAS blocker
• Heart failure with reduced ejection fraction
• Combination of prior myocardial infarction and diabetes mellitus
• Diabetic nephropathy,

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Department of medical sciences, Uppsala University

Uppsala, 751 05, Sweden

Location

MeSH Terms

Interventions

Adrenergic beta-Antagonists

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: September 3, 2010
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

SE (1)