Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01057537 | UMPIRE - Use of a Multidrug Pill In Reducing Cardiovascular Events | PHASE3 | COMPLETED | 2,004 | — | — | Jun 1, 2010 | Sep 1, 2012 | Nov 27, 2012 | 7 | Australia, India +3 |
| Arm | Type | Description |
|---|---|---|
| polypill | EXPERIMENTAL | Red Heart Pill Version 1 and Red Heart Pill Version 2. In general, participants with a history of coronary heart disease will be given version 1, and those with a history of stroke or cerebrovascular disease will be given version 2. |
| Usual Care | ACTIVE_COMPARATOR | Participants in the usual care arm will take their usual cardiovascular medications. The participants will be seen as needed by their usual doctor between study visits. |
| Name | Type | Description |
|---|---|---|
| polypill | DRUG | The polypill will be taken once/day in the form of a hard capsule, to be taken orally. There are two versions of the polypill (Red Heart Pill): Version 1 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Atenolol 50mg; Version 2 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Hydrochlorothiazide 12.5mg. |
| Usual cardiovascular medications | DRUG | Participants in the 'Usual Care' arm will continue to take the separate, individual medications prescribed by their usual doctor, e.g. aspirin, blood pressure lowering drugs, statins. |
Inclusion Criteria: * Adults (≥ 18 years) * The participant is able to give informed consent. * Established atherothrombotic cardiovascular disease (CVD) or high cardiovascular risk, of for individuals without established cardiovascular disease, a calculated 5 year CVD risk of 15% or greater (calcu...