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

Inflammation Clinical Trial

— DOLPHIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02870764
• Other study ID #: TaizhouFPH-001
• Status: Recruiting
• Phase: Phase 4
• First received: August 13, 2016
• Last updated: September 11, 2016
• Start date: September 2016
• Est. completion date: August 2017

Study information

• Verified date: September 2016
• Source: Taizhou Fourth People's Hospital
• Contact: Chunling Wang, Bachelor
• Phone: 008613921709559
• Email: 59201291[@]qq.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Inflammation

Intervention

Drug:
• Dan-shen extract
A kind of injection made from a kind of Chinese herb: salvia miltiorrhiza
• Placebo
200mg glugose added into 250ml 0.9% saline injection by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.

Other:
• Standard medical care
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).

Locations

Country	Name	City	State
China	Taizhou Fourth People's Hospital	Taizhou	Jiangsu

Sponsors (2)

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

Country where clinical trial is conducted

China, 

References & Publications (6)

Cai A, Li G, Chen J, Li X, Li L, Zhou Y. Increased serum level of Lp-PLA2 is independently associated with the severity of coronary artery diseases: a cross-sectional study of Chinese population. BMC Cardiovasc Disord. 2015 Feb 26;15:14. doi: 10.1186/s12872-015-0001-9. — View Citation

Cheng TO. Cardiovascular effects of Danshen. Int J Cardiol. 2007 Sep 14;121(1):9-22. Epub 2007 Mar 23. Review. — View Citation

Li B, Wang Y, Lu J, Liu J, Yuan Y, Yu Y, Wang P, Zhao X, Wang Z. Evaluating the effects of Danhong injection in treatment of acute ischemic stroke: study protocol for a multicenter randomized controlled trial. Trials. 2015 Dec 9;16:561. doi: 10.1186/s13063-015-1076-4. — View Citation

Wang PQ, Li DD, Dong W, Liu J, Yu YN, Shen CT, Chen QG, Chen BW, Chen YD, Wang Z. Danhong injection in the treatment of chronic stable angina: study protocol for a randomized controlled trial. Trials. 2015 Oct 21;16:474. doi: 10.1186/s13063-015-0998-1. — View Citation

White HD, Simes J, Stewart RA, Blankenberg S, Barnes EH, Marschner IC, Thompson P, West M, Zeller T, Colquhoun DM, Nestel P, Keech AC, Sullivan DR, Hunt D, Tonkin A; LIPID Study Investigators. Changes in lipoprotein-Associated phospholipase A2 activity predict coronary events and partly account for the treatment effect of pravastatin: results from the Long-Term Intervention with Pravastatin in Ischemic Disease study. J Am Heart Assoc. 2013 Oct 23;2(5):e000360. doi: 10.1161/JAHA.113.000360. — View Citation

Yao Y, Feng Y, Lin W. Systematic review and meta-analysis of randomized controlled trials comparing compound danshen dripping pills and isosorbide dinitrate in treating angina pectoris. Int J Cardiol. 2015 Mar 1;182:46-7. doi: 10.1016/j.ijcard.2014.12.112. Epub 2014 Dec 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum level of Lp-PLA2		up to Day 60 after discharge	No
Secondary	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	No
Secondary	carotid arterial intima-media wall thickness		Day0 and Day 60 after discharge	No
Secondary	Canadian Cardiovascular Society (CCS) grading of angina pectoris		Day 0 and Day 60 after discharge	No
Secondary	Change in the electrocardiogram (EKG)		Day 0 and Day 60 after discharge	No
Secondary	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	No
Secondary	Incidence of new-onset major vascular events	Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.	up to 60 days after discharge	Yes
Secondary	Incidence of severe hemorrhages	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.	up to 60 days after discharge	Yes
Secondary	Incidence of moderate hemorrhages	The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.	up to 60 days after discharge	Yes