The Effect of Dan-shen Extract On Lipoprotein Associated PHospholipase A2 Levels IN Patients With Stable Angina Pectoris

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled, adaptive clinical trial, which will assess the effect of DanshenDuofensuanyan[Danshen (a kind of Chinese herbal drug) extract] treatment on Lipoprotein associated phospholipase A2 level in patients with stable angina pectoris.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taizhou Fourth People's Hospital
• Collaborator: Shanghai 10th People's Hospital

Criteria

Inclusion Criteria:

1. Age:18 years-75 years;

2. Written informed consent;

3. Patients with a clinical diagnosis of chronic stable angina, which fulfil one of the following conditions:

1. Symptoms that support the diagnosis of chronic angina and/or a history of an abnormal exercise response limited by angina and/or electrocardiograph (ECG) changes

2. a history of myocardial infarction and ST-T changes,

3. stenosis of more than 50 % in at least one major epicardial coronary artery, as shown by coronary angiography or computed tomography angiography,

4. Coronary heart disease confirmed by radionuclide angiocardiography;

4. Patients with moderate angina pectoris, which is defined as Grade II or III on the Canadian Cardiovascular Society Angina Grading Scale.

Exclusion Criteria:

1. Patients with severe complications that would complicate the condition, as assessed by the investigator, including liver or renal dysfunction, severe cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, a history of epilepsy or cerebral haemorrhage.

2. Patients who were angina-free during the run-in period without taking any drug.

3. Patients who experienced myocardial infarction or who were classified as Grade IV on the Canadian Cardiovascular Society Angina Grading Scale within the preceding 3 months.

4. Patients with chest pain that is caused by any other disease (e.g., acute myocardial infarction, severe neurosis, menopausal syndrome or hyperthyroidism).

5. Patients with a history of drug-induced bleeding or a history of bleeding caused by warfarin.

6. Patients with a history of haematopoietic disorder.

7. Patients who have had surgery within the previous 4 weeks or who have a haemorrhagic tendency.

8. Women who are pregnant or lactating or who have a positive pregnancy test, or women who have a menstrual period at baseline.

9. Patients who are participating in other trials or who have participated in other trials within the past 3 months.

10. Patients with a history of allergy or with a known or suspected allergy to the study drug.

11. Patients with a known or suspected history of alcohol or drug abuse within the past 2 years.

12. Patients with a mental disorder.

13. Family members or relatives of the study centre staff.

14. Inability to adhere to study procedures