Prospective randomized controlled trial study of Luofengning Granule in the treatment of unstable angina

Phase 1

Not yet recruiting

• Conditions: nstable angina

• Registration Number: ITMCTR2000003090
• Lead Sponsor: Xian Wang

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. Confirmed UA patients;
2. Aged 18 to 80 years;
3. No gender restriction;
4. According to the requirements of GCP, the subjects will sign the informed consent form knowingly and voluntarily.

Exclusion Criteria

1. Patients with diagnosis of AMI, stroke or undergone PCI or coronary artery bypass grafting (CABG) within 1 month prior to enrollment;
2. Patients with coexistent severe heart failure (NYHA, Class IV) and severe arrhythmia (atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, sinus bradycardia (heart rate < 55), complete left bundle branch block;
3. With combined liver and kidney dysfunction, liver function (ALT, AST) 3 times higher than the upper limit of normal renal function, creatinine clearance rate (CrCl) less than 30 ml/min/1.73m2;
4. With poorly controlled hypertension (systolic pressure >= 160mmHg or diastolic blood pressure >= 100mmHg);
5. With the terminal phase cachexia of malignant tumors;
6. With high bleeding risk,such as history of hemorrage of vital organs (brain or upper gastrointestinal tract) within 6 months, low platelet counts, abnormal coagulation function, recent active hemorrhage,etc.;
7. Patients with bleeding tendency within 1 month after operation;
8. Women who are under breastfeeding, pregnant or preparing for pregnancy;
9. With poor compliance;
10. Patients with known or suspected allergy to the test drug or allergic constitution;
11. Patients who participate in any other clinical study or take any of its investigational drugs within the last three months.

Study & Design

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