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

A Randomized, Double-blind, Placebo-controlled Trial of Dan-shen Extract in Patients With Stable Angina Pectoris

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.

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