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

Phase 4

• Conditions: Angina, Stable; Inflammation
• Interventions: Drug: Placebo; Drug: Dan-shen extract; Other: Standard medical care

• Registration Number: NCT02870764
• Lead Sponsor: Taizhou Fourth People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-13
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-17
• Status Verified: 2016-09
• Study Start: 2016-09
• Last Update Submitted: 2016-09-11
• Last Update Posted: 2016-09-13
• Primary Completion: 2017-05
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dan-shen extract	Standard medical care	Based on the standard medical care, 200mg of Danshenduofensuanyan, added into 250ml of 0.9% saline injection, given by continuous IV infusion at 2.5ml/min within 2 hours, once a day during the patients' hospitalization. Danshen drop spill (30 pill/day) taken orally for 60 days after discharge.
Placebo	Placebo	Based on the standard medical care, placebo was 200mg of glucose, added into 250ml of 0.9% saline injection, given by continuous IV infusion at 2.5ml/min within 2 hours.
Dan-shen extract	Dan-shen extract	Based on the standard medical care, 200mg of Danshenduofensuanyan, added into 250ml of 0.9% saline injection, given by continuous IV infusion at 2.5ml/min within 2 hours, once a day during the patients' hospitalization. Danshen drop spill (30 pill/day) taken orally for 60 days after discharge.
Placebo	Standard medical care	Based on the standard medical care, placebo was 200mg of glucose, added into 250ml of 0.9% saline injection, given by continuous IV infusion at 2.5ml/min within 2 hours.

Primary Outcome Measures

Name	Time	Method
Serum level of Lp-PLA2	up to Day 60 after discharge

Secondary Outcome Measures

Name	Time	Method
Incidence of new-onset major vascular events	up to 60 days after discharge	Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.
carotid arterial intima-media wall thickness	Day0 and Day 60 after discharge
Canadian Cardiovascular Society (CCS) grading of angina pectoris	Day 0 and Day 60 after discharge
Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate	Day 0 and Day 60 after discharge
The proportion of patients in each treatment group who had clinically significant change as defined by the angina-frequency score on the Seattle Angina Questionnaire	Day 0 and Day 60 after discharge
Change in the electrocardiogram (EKG)	Day 0 and Day 60 after discharge
Incidence of severe hemorrhages	up to 60 days after discharge	The definition of "Severe hemorrhages" is in accordance with the GUSTO bleeding criteria, including fatal intracranial hemorrhage (ICH), symptomatic intracerebral hemorrhage (sICH) or which could result in substantial hemodynamic compromise requiring treatment.
Incidence of moderate hemorrhages	up to 60 days after discharge	The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.

Trial Locations

Locations (1)

Taizhou Fourth People's Hospital; 🇨🇳 Taizhou, Jiangsu, China