drugset / Trial / NCT02559414
Antiplatelet Therapy in HIV
RandomizedParallel-groupSingle-blindPrevention
Summary
The proposed study will add to the growing understanding of platelet activity and platelet inhibition in subjects with HIV. It will examine the relationship between platelet activity and its inhibition by antiplatelet therapy (aspirin monotherapy and clopidogrel monotherapy) in this high-risk cohort. Furthermore, it will provide important data on the mechanism of platelet activity and its inhibition using biomarkers of platelet activity, inflammation, immune activity and endothelial function and genetic expression profiling.
Timeline
- Start
- 2015-02
- Primary completion
- 2016-04
- Completion
- 2017-02
Publications
- Background Berger JS, Lala A, Krantz MJ, Baker GS, Hiatt WR. Aspirin for the prevention of cardiovascular events in patients without clinical cardiovascular disease: a meta-analysis of randomized trials. Am Heart J. 2011 Jul;162(1):115-24.e2. doi: 10.1016/j.ahj.2011.04.006.
- Background Berger JS, Roncaglioni MC, Avanzini F, Pangrazzi I, Tognoni G, Brown DL. Aspirin for the primary prevention of cardiovascular events in women and men: a sex-specific meta-analysis of randomized controlled trials. JAMA. 2006 Jan 18;295(3):306-13. doi: 10.1001/jama.295.3.306.
- Background CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet. 1996 Nov 16;348(9038):1329-39. doi: 10.1016/s0140-6736(96)09457-3.
- Background Solomon Tsegaye T, Gnirss K, Rahe-Meyer N, Kiene M, Kramer-Kuhl A, Behrens G, Munch J, Pohlmann S. Platelet activation suppresses HIV-1 infection of T cells. Retrovirology. 2013 May 1;10:48. doi: 10.1186/1742-4690-10-48.
- Marcantoni E, Garshick MS, Schwartz T, Ratnapala N, Cambria M, Dann R, O'Brien M, Heguy A, Berger JS. Antiplatelet Effects of Clopidogrel Vs Aspirin in Virologically Controlled HIV: A Randomized Controlled Trial. JACC Basic Transl Sci. 2022 Oct 5;7(11):1086-1097. doi: 10.1016/j.jacbts.2022.06.002. eCollection 2022 Nov.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aspirin | Small molecule | 81 mg | — |
| Comparator | Clopidogrel | Small molecule | — | — |