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

NCT ID: NCT02870764

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-08-31

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.

Conditions

Angina, Stable; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dan-shen extract

Intervention Type: DRUG

A kind of injection made from a kind of Chinese herb: salvia miltiorrhiza

Standard medical care

Intervention Type: OTHER

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Standard medical care

Intervention Type: OTHER

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

Interventions

Dan-shen extract

A kind of injection made from a kind of Chinese herb: salvia miltiorrhiza

Intervention Type: DRUG

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.

Intervention Type: DRUG

Standard medical care

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

Intervention Type: OTHER

Other Intervention Names

salvianolic acid; Depside salt from Salvia Miltiorrhiza; Danshen Dropping Pill; dropping salvia pill

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: collaborator

Taizhou Fourth People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

ChunLing Wang

Attending Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

A'Di Chen, Master

Role: STUDY_CHAIR

Taizhou Fourth People's Hospital

Locations

Taizhou Fourth People's Hospital

Taizhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chunling Wang, Bachelor

Role: CONTACT

59201291@qq.com

008613921709559

Facility Contacts

Bailing Su, MD

Role: primary

tzsybgs055@sina.com

0086052380185012

Haoshen Wang, MD

Role: backup

billet1116@163.com

008613952613616

References

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.

Reference Type: BACKGROUND

PMID: 26654631 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26489511 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 25585358 (View on PubMed)

Cheng TO. Cardiovascular effects of Danshen. Int J Cardiol. 2007 Sep 14;121(1):9-22. doi: 10.1016/j.ijcard.2007.01.004. Epub 2007 Mar 23.

Reference Type: BACKGROUND

PMID: 17363091 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25879827 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24152981 (View on PubMed)

Chen AD, Wang CL, Qin Y, Tian L, Chen LB, Yuan XM, Ma LX, Wang YF, Sun JR, Wang HS, Dai N; DOLPHIN investigator group. The effect of Danshen extract on lipoprotein-associated phospholipase A2 levels in patients with stable angina pectoris: study protocol for a randomized controlled trial - the DOLPHIN study. Trials. 2017 Dec 20;18(1):606. doi: 10.1186/s13063-017-2336-2.

Reference Type: DERIVED

PMID: 29262859 (View on PubMed)

Other Identifiers

TaizhouFPH-001

Identifier Type: -

Identifier Source: org_study_id