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

NCT02870764 | Unknown Phase 4 DMC

• 1 other identifier: TaizhouFPH-001
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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

Keywords

Danshenduofensuanyan; Lp-PLA2; coronary artery disease; Salvia miltiorrhiza

Outcome Measures

Primary Outcomes (1)

• Serum level of Lp-PLA2

  up to Day 60 after discharge

Secondary Outcomes (8)

• 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

• 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

• Change in the electrocardiogram (EKG)

  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

Study Arms (2)

Dan-shen extract

ACTIVE COMPARATOR

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.

Drug: Dan-shen extract; Other: Standard medical care

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo; Other: Standard medical care

Interventions

Dan-shen extract DRUG

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

Also known as: salvianolic acid, Depside salt from Salvia Miltiorrhiza, Danshen Dropping Pill, dropping salvia pill

Dan-shen extract

Placebo 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.

Placebo

Standard medical care OTHER

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

Dan-shen extract; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age:18 years-75 years;
• Written informed consent;
• Patients with a clinical diagnosis of chronic stable angina, which fulfil one of the following conditions:
• 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
• a history of myocardial infarction and ST-T changes,
• stenosis of more than 50 % in at least one major epicardial coronary artery, as shown by coronary angiography or computed tomography angiography,
• Coronary heart disease confirmed by radionuclide angiocardiography;
• Patients with moderate angina pectoris, which is defined as Grade II or III on the Canadian Cardiovascular Society Angina Grading Scale.

You may not qualify if:

• 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.
• Patients who were angina-free during the run-in period without taking any drug.
• 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.
• Patients with chest pain that is caused by any other disease (e.g., acute myocardial infarction, severe neurosis, menopausal syndrome or hyperthyroidism).
• Patients with a history of drug-induced bleeding or a history of bleeding caused by warfarin.
• Patients with a history of haematopoietic disorder.
• Patients who have had surgery within the previous 4 weeks or who have a haemorrhagic tendency.
• Women who are pregnant or lactating or who have a positive pregnancy test, or women who have a menstrual period at baseline.
• Patients who are participating in other trials or who have participated in other trials within the past 3 months.
• Patients with a history of allergy or with a known or suspected allergy to the study drug.
• Patients with a known or suspected history of alcohol or drug abuse within the past 2 years.
• Patients with a mental disorder.
• Family members or relatives of the study centre staff.
• Inability to adhere to study procedures

Sponsors & Collaborators

• Taizhou Fourth People's Hospital: lead
• Shanghai 10th People's Hospital: collaborator

Study Sites (1)

Taizhou Fourth People's Hospital

Taizhou, Jiangsu, 225300, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 26654631 BACKGROUND

• 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.

  PMID: 26489511 BACKGROUND

• 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.

  PMID: 25585358 BACKGROUND

• 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.

  PMID: 17363091 BACKGROUND

• 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.

  PMID: 25879827 BACKGROUND

• 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.

  PMID: 24152981 BACKGROUND

• 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.

  PMID: 29262859 DERIVED

MeSH Terms

Conditions

Angina, Stable; Inflammation; Coronary Artery Disease

Interventions

dan-shen root extract; salvianolic acid

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• A'Di Chen, Master

  Taizhou Fourth People's Hospital

  STUDY CHAIR

Central Study Contacts

Chunling Wang, Bachelor

CONTACT

008613921709559; 59201291@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: August 13, 2016
• First Posted: August 17, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 13, 2016

Record last verified: 2016-09

Locations

CN (1)