Trials / Active Not Recruiting
Active Not RecruitingNCT04036409
Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Stroke Patients
A Randomized Controlled Trial to Assess the Effect of Intensive Blood Pressure Control on Major Cardiovascular Events in Stroke Patients
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4,368 (actual)
- Sponsor
- Hospital Israelita Albert Einstein · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Elevated blood pressure (BP) consists of a major public health concern especially in low and middle income countries. Besides being a highly prevalent condition, it is also a risk factor for several major cardiovascular events including stroke (which consists of the second leading cause of death in developing countries) and coronary artery disease, and is also related to cognitive decline. The OPTIMAL Stroke trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower target systolic blood pressure (SBP) as compared to the currently recommended target for stroke patients will reduce the occurrence of major cardiovascular events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Intensive Control of Systolic Blood Pressure (SBP) | Participants in the Intensive arm have a goal of SBP \<120 mm Hg. The use of angiotensin converting enzyme (ACE)-inhibitors/Angiotension receptor blockers (ARBs), Thiazide-type diuretics, calcium channel blockers (CCB), Sustained-release calcium channel blockers (CCBs) will be encouraged, preferably fixed-dose combinations of indapamide + perindopril arginine, perindopril arginine + amlodipine or indapamide + perindopril arginine +amlodipine |
| DRUG | Standard control of Systolic Blood Pressure (SBP) | The same medications used in the Intensive BP arm will be used for the Standard BP arm. |
Timeline
- Start date
- 2019-08-05
- Primary completion
- 2026-05-28
- Completion
- 2026-05-28
- First posted
- 2019-07-29
- Last updated
- 2026-04-16
Locations
30 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT04036409. Inclusion in this directory is not an endorsement.