Efficacy and safety of INtensive treatment versus standard treatment of COmpound DanshEn dripping pills in Refractory angina patients with incomplete revascularization (INCODER study): a multicenter, randomized, double-blind, parallel controlled clinical trial

The First Affiliated Hospital, Sun Yat-sen University0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1. Aged 18 to 85 years;
•2. Had a history of coronary artery disease with refractory angina [Canadian Cardiovascular Society (CCS) class II to III] despite optimal medical therapy for at least one month;
•Optimal medical therapy is defined as guideline-recommended treatment including secondary prevention and at least two antianginal drugs: one is nitrates, another is beta-blocker or calcium channel blocker, except for medication contraindications;
•3. With incomplete revascularization (ICR).
•ICR is defined as the presence of >=1 lesion with visually estimated >=50% diameter stenosis in any coronary artery (including branch vessels) of >=2.0 mm in diameter, whether in the target vessel or in a nontarget vessel. In the case of a participant post-CABG, ICR is defined as the presence of >=1 lesion with visually estimated >=50% diameter stenosis in a nonbypassed epicardial vessel >=2.0 mm in diameter, or >=1 visually estimated >=50% diameter stenosis in a bypass graft supplying an otherwise nonrevascularized myocardial territory.
•4. The ejection fraction >=30%;
•5. Willing to sign the informed consent form.

•1. Acute coronary syndrome within 1 month or planned coronary revascularization during the study period;
•2. Episode of transient ischemia attack, ischemic or hemorrhagic stroke within 2 months;
•3. Presence of neuromuscular, orthopedic or other non-cardiac condition such as severe peripheral artery disease, severe pulmonary hypertension and uncontrolled chronic obstructive pulmonary disease or asthma that prevents the patient from exercise testing on a cycle ergometer;
•4. Patients with the following resting electrocardiographic abnormalities that might influence the interpretation of the termination of CPET:
•-Pre-excitation (Wolff-Parkinson-White) syndrome;
•-Electronically paced ventricular rhythm;
•-1 mm or more of resting ST depression
•-Complete left bundle-branch block or any interventricular conduction defect with a QRS duration greater than 120 ms
•5. Uncontrolled symptomatic heart failure;
•6. Moderate to severe symptomatic aortic stenosis;
•7. Hypertrophic cardiomyopathy;
•8. Acute myocarditis or pericarditis;
•9. Active endocarditis;
•10. Acute pulmonary embolism;
•11. Suspected or known acute aortic dissection;
•12. Severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg at screening)
•13. Severe anemia (Hemoglobin < 60 g/L);
•14. Active psychosis requiring anticonvulsant treatment;
•15. Pregnant or lactating women.
•16. Participation in other clinical studies within 30 days before the first visit.

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