Acute Myocardial InfarctionPhase 3NCT03541109
A Polypill for Secondary Prevention of Ischemic Heart Disease
A Phase 3 study testing Polypill in people with Acute Myocardial Infarction and ST Elevation Myocardial Infarction, run by Isfahan University of Medical Sciences at 2 sites in Iran.
Trial summary
Cardiovascular diseases (CVD) are the leading cause of mortality and morbidity worldwide. The most important aspect of CVD secondary prevention is adherence to guideline-indicated pharmacological therapy which globally remains low. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction
- What is being tested?
- Polypill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 2 sitesIran
- Study dates
- 20 May 2019to Aug 2024
- Phase
- Phase 3
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized because of an acute myocardial infarction (STEMI/NSTEMI) and alive after discharge for at least 1 month
- signing informed consent
- clear indication of receiving all components of Polypill (aspirin, statin, ACE inhibitor/ARB, and beta blocker)
- living in Isfahan city or nearby areas so that they can attend follow-ups
- No mental illness limiting their self-care ability or Severe illness with an estimated lifespan of less than 3 years
- No history of adverse reaction or contraindication to any component of the Polypill
- Not having Secondary hyperlipidemia, serum creatinine ≥ 2, severe heart failure
- No plan for a procedure (CABG, PCI, or another surgical procedures) within following 6 months
Who cannot join
- Patient unlikely to complete trial
- Need to change or discontinue any of the four principal drugs of the Polypill to achieve better control of the disease or risk factors or because of adverse drug reactions (based on physician's idea)
- Severe illness with an estimated lifespan of less than 3 years
Trial locations and contacts
2 sites in 1 country.
Shervin Ghaffari Hoseini, MD,PhD contact
Iran2 sites, 2 recruiting
- Recruiting
Chamran cardiology hospital
Isfahan, 814651148
Maryam Kelardasht, MS, 00983136115313, Kelardasht@yahoo.com
- Recruiting
Cardiovascular Research Institute
Isfahan
Safoora yazdekhasti, 00983136115208, sfa.yazdekhasti@gmail.com
Nizal Sarrafzadegan, Professor
About this study
Official title: Fixed Combination Therapy for Secondary Prevention of Major Cardiovascular Events
Cardiovascular diseases (CVD) are the leading cause of mortality and morbidity worldwide. The most important aspect of CVD secondary prevention is adherence to guideline-indicated pharmacological therapy which globally remains low. In previous studies, a Polypill containing fixed dose combination of essential drugs have improved patient adherence to these drugs. The effect of such a strategy on pharmacological therapy uptake, cost-effectiveness, and CVD recurrence in our setting will be assessed in this study. Participants hospitalized in three referral hospitals in Isfahan, Iran because of an acute myocardial infarction (MI) (ST elevation MI (STEMI) or non-ST elevation MI (NSTEMI)) will be randomized to either receiving Polypill or usual care after MI. Patient recruitment will be carried out at the time of patient discharge from the hospitals.
- Conditions
- Acute Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction
- Being tested
- Polypill
- Keywords
- Cardiovascular disease, fixed dose combination therapy, cost effectiveness
- Medical subject headings
- ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolypillDrug
Also called Polypill-S
fixed dose combination of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg)
| Study group | Role | What they receive |
|---|---|---|
| Polypill | Experimental | Polypill group will receive a fixed dose combinations of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg), prescribed once daily by moth for 34 months Receives: Drug: Polypill |
| Control | No intervention | The usual care arm will receive regular drug order at the time of discharge from the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite clinical outcome of major adverse cardiovascular events (MACE)
MACE includes cardiac death, fatal/nonfatal MI or stroke, hospitalization due to acute coronary syndrome/acute cerebrovascular accident, revascularization procedures, development or worsening of HF, and development of persistent new AF.
Measured: from time of randomization up to 34 months
Secondary outcomes (1)
cost-effectiveness of Polypill treatment compared with usual care
The analysis will be done on direct and indirect costs of treatment. Direct costs will be assessed from perspective of health care system. Current Iranian public medical tariffs will be the base of calculations. The incremental cost effectiveness ratio (ICER) will be calculated for primary outcomes.
Measured: up to 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start20 May 2019
- Primary completionAug 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Tehran University of Medical Sciences
- Responsible party
- Principal investigator, Masoumeh Sadeghi, Isfahan University of Medical Sciences
- Investigators
- Masoumeh Sadeghi, professor, Principal investigator, Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541109
- Sponsor's protocol ID
- Persian Polypill
- Status last verified
- Oct 2020
- First submitted
- 17 May 2018
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixed Combination Therapy for Secondary Prevention of Major Cardiovascular Events
- ClinicalTrials.gov ID
- NCT03541109
- Acronym / sponsor ID
- Persian Polypill
- Conditions
- Acute Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction
- Keywords
- Cardiovascular disease, fixed dose combination therapy, cost effectiveness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Collaborators
- Tehran University of Medical Sciences
- Study start
- 20 May 2019 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 30 May 2018 (actual)
- 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.
Cardiovascular diseases (CVD) are the leading cause of mortality and morbidity worldwide. The most important aspect of CVD secondary prevention is adherence to guideline-indicated pharmacological therapy which globally remains low. In previous studies, a Polypill containing fixed dose combination of essential drugs have improved patient adherence to these drugs. The effect of such a strategy on pharmacological therapy uptake, cost-effectiveness, and CVD recurrence in our setting will be assessed in this study. Participants hospitalized in three referral hospitals in Isfahan, Iran because of an acute myocardial infarction (MI) (ST elevation MI (STEMI) or non-ST elevation MI (NSTEMI)) will be randomized to either receiving Polypill or usual care after MI. Patient recruitment will be carried out at the time of patient discharge from the hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polypill | Experimental | Drug: PolypillPolypill group will receive a fixed dose combinations of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg), prescribed once daily by moth for 34 months |
| Control | No intervention | –The usual care arm will receive regular drug order at the time of discharge from the hospital. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients hospitalized because of an acute myocardial infarction (STEMI/NSTEMI) and alive after discharge for at least 1 month
- signing informed consent
- clear indication of receiving all components of Polypill (aspirin, statin, ACE inhibitor/ARB, and beta blocker)
- living in Isfahan city or nearby areas so that they can attend follow-ups
- No mental illness limiting their self-care ability or Severe illness with an estimated lifespan of less than 3 years
Key exclusion criteria (3 listed)
- Patient unlikely to complete trial
- Need to change or discontinue any of the four principal drugs of the Polypill to achieve better control of the disease or risk factors or because of adverse drug reactions (based on physician's idea)
- Severe illness with an estimated lifespan of less than 3 years
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 |
|---|---|---|
| PolypillAlso: Polypill-Sfixed dose combination of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg) | Drug | Polypill |
Primary outcome
A composite clinical outcome of major adverse cardiovascular events (MACE)
Time frame: from time of randomization up to 34 months
MACE includes cardiac death, fatal/nonfatal MI or stroke, hospitalization due to acute coronary syndrome/acute cerebrovascular accident, revascularization procedures, development or worsening of HF, and development of persistent new AF.
1 secondary outcome
cost-effectiveness of Polypill treatment compared with usual care
Time frame: up to 34 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Yes
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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.
Shervin Ghaffari Hoseini, MD,PhD contact
Masoumeh Sadeghi, professor principal investigator
Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polypill in people with Acute Myocardial Infarction and ST Elevation Myocardial Infarction, run by Isfahan University of Medical Sciences at 2 sites in Iran.
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 8 inclusion and 3 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Masoumeh Sadeghi, Professor (00989134091776, sadeghimasoumeh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite clinical outcome of major adverse cardiovascular events (MACE) (time frame: from time of randomization up to 34 months). 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 14 Oct 2020.