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

Phase 4

Recruiting

• Conditions: refractory angina with incomplete revascularization

• Registration Number: ITMCTR2000003248
• Lead Sponsor: The First Affiliated Hospital, Sun Yat-sen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the change in total exercise time from baseline to week 6;