Trial no.:
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PACTR202112803123592 |
Date of Approval:
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02/12/2021 |
Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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TRIAL DESCRIPTION |
Public title
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RIC-AFRICA |
Official scientific title |
Remote Ischaemic Conditioning in STEMI patients in sub-Saharan AFRICA: The RIC-AFRICA trial |
Brief summary describing the background
and objectives of the trial
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Background: Although remote ischaemic conditioning (RIC) has been shown to reduce myocardial infarct size in animal studies and ST-segment elevation myocardial infarction (STEMI) patients, it failed to improve clinical outcomes in the large CONDI-2/ERIC-PPCI trial. This may have been due to the low-risk patients recruited into the study and the fact that patients received optimal reperfusion therapy by primary percutaneous coronary intervention. In the RIC-AFRICA trial, we will investigate whether RIC can improve clinical outcomes in higher-risk STEMI patients in sub-Saharan Africa where reperfusion therapy is suboptimal.
Study design: The RIC-AFRICA study is a sub-Saharan African multi-centre, randomized sham-controlled clinical trial designed to test the impact of RIC on the composite endpoint of 30-day mortality and heart failure in 1200 adult STEMI patients without access to PPCI. Randomized participants will be stratified by whether or not they receive thrombolytic therapy within 12 hours or arrive too late for thrombolytic therapy. Participants will receive either RIC (four 5-minute cycles of inflation [20mmHg above systolic blood pressure] and deflation of an upper arm cuff) or sham-control (similar protocol but with low-pressure inflation and deflation) within 1hour of thrombolysis and applied daily for the next 2 days. STEMI patients arriving greater than 24 hours after chest pain but within 72 hours will be recruited to participate in an observational arm. All participants will be telephonically contacted at 30 days to determine their outcome.
Implications: The RIC-AFRICA trial will determine whether RIC can reduce rates of death and heart failure in higher-risk STEMI patients in sub-Saharan Africa where reperfusion therapy is suboptimal, thereby providing a low-cost, non-invasive therapy for improving health outcomes. |
Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
RIC AFRICA |
Disease(s) or condition(s) being studied |
Cardiology,Circulatory System |
Sub-Disease(s) or condition(s) being studied |
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Purpose of the trial |
Treatment: Devices |
Anticipated trial start date |
06/12/2021 |
Actual trial start date |
03/01/2022 |
Anticipated date of last follow up |
01/02/2024 |
Actual Last follow-up date |
01/02/2023 |
Anticipated target sample size (number of participants) |
1200 |
Actual target sample size (number of participants) |
1200 |
Recruitment status |
Active, not recruiting |
Publication URL |
https://link.springer.com/article/10.1007/s10557-021-07283-y |
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