China Tongxinluo study for myocardial protection in patients with acute myocardial infarction (CTS-AMI): Rationale and Design of a Randomized, double-blind, placebo-controlled, multi-center clinical trial

Abstract Background Acute ST-segment elevation myocardial infarction (STEMI) remains a serious life-threatening event. Despite coronary revascularization, patients might still suffer from poor outcomes caused by myocardial no-reflow and ischemic/reperfusion injury. Tongxinluo (TXL), a traditional Chinese medicine, has been preliminarily demonstrated to reduce myocardial no-reflow and ischemic/reperfusion injury. We further hypothesize that TXL treatment is also effective in reducing clinical endpoints for the patients with STEMI. Methods and Results. The CTS-AMI trial is a prospective, randomized, double-blind, placebo-controlled, multi-center clinical study in China. An estimated 3796 eligible patients with STEMI from about 120 centers are randomized 1:1 ratio to TXL or placebo groups. All enrolled patients are orally administrated a loading dose of 8 capsules of TXL or placebo together with dual anti-platelet agents on admission, followed by 4 capsules three times a day until 12 months. The primary endpoint is 30-day major adverse cardiovascular and cerebrovascular events (MACCE), a composite of cardiac death, myocardial re-infarction, emergency coronary revascularization, and stroke. Secondary endpoints include each component of the primary endpoint, 1-year MACCE and other efficacy and safety parameters. Conclusion Results of CTS-AMI trial will determine the clinical efficacy and safety of traditional Chinese medicine TXL capsule in the treatment of STEMI patients in the reperfusion era.