Mono- Versus Dual antiPlatelet Therapy During 6-12 Months After New Generation Drug Eluting Stent Implantation
Summary
Long-term DAPT is recommended after percutaneous coronary intervention (PCI) in patients with coronary artery disease. However, antiplatelet therapy may have adverse consequences, the most common of which is gastrointestinal mucosal injury with ulceration and bleeding. The extent to which an an abbreviated DAPT strategy reduces gastrointestinal mucosal injury has not been studied, principally due to the lack of sensitive, noninvasive measurements capable of detecting gastrointestinal injury.ANKON® magnetically controlled capsule endoscopy (AMCE) is a non-invasive, active controlled system which affords assessment of the stomach and entire small intestine.The current randomized study will assess gastrointestinal mucosal injury and bleeding via AMCE in patients on three different antiplatelet regimens and establish a gastrointestinal mucosal injury scoring system which may prove useful in guiding optimal antiplatelet agent usage after PCI.
Timeline
- Start
- 2017-07-13
- Primary completion
- 2020-08-13
- Completion
- 2020-08-13
Publications
- Background Li Y, Wang X, Bao D, Liao Z, Li J, Han X, Wang H, Xu K, Li Z, Stone GW, Han Y. Optimal antiplatelet therapy for prevention of gastrointestinal injury evaluated by ANKON magnetically controlled capsule endoscopy: Rationale and design of the OPT-PEACE trial. Am Heart J. 2020 Oct;228:8-16. doi: 10.1016/j.ahj.2020.06.004. Epub 2020 Jun 15.
- Background Han Y, Liao Z, Li Y, Zhao X, Ma S, Bao D, Qiu M, Deng J, Wang J, Qu P, Jiang C, Jia S, Yang S, Ru L, Feng J, Gao W, Huang Y, Tao L, Han Y, Yang K, Wang X, Zhang W, Wang B, Li Y, Yang Y, Li J, Sheng J, Ma Y, Cui M, Ma S, Wang X, Li Z, Stone GW. Magnetically Controlled Capsule Endoscopy for Assessment of Antiplatelet Therapy-Induced Gastrointestinal Injury. J Am Coll Cardiol. 2022 Jan 18;79(2):116-128. doi: 10.1016/j.jacc.2021.10.028. Epub 2021 Nov 6.
- He C, Li Y, Jiang X, Jiang MN, Zhao XX, Ma SR, Bao D, Qiu MH, Deng J, Wang JH, Qu P, Jiang CM, Jia SB, Yang SQ, Ru LS, Feng J, Gao W, Huang YH, Tao L, Han Y, Yang K, Wang XY, Zhang WJ, Wang BM, Li Y, Yang YL, Li JX, Sheng JQ, Ma YT, Cui M, Ma SC, Wang XZ, Li ZS, Liao Z, Han YL, Stone GW. Progression of Gastrointestinal Injury During Antiplatelet Therapy After Percutaneous Coronary Intervention: A Secondary Analysis of the OPT-PEACE Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2343219. doi: 10.1001/jamanetworkopen.2023.43219.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aspirin | Small molecule | 100 mg | — |
| Comparator | Clopidogrel | Small molecule | 75 mg | — |