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

Primary Purpose

Angina, Stable, Inflammation

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Dan-shen extract

Placebo

Standard medical care

About this trial

This is an interventional treatment trial for Angina, Stable focused on measuring Danshenduofensuanyan, Lp-PLA2, coronary artery disease, Salvia miltiorrhiza

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age:18 years-75 years;
Written informed consent;
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;
Patients with moderate angina pectoris, which is defined as Grade II or III on the Canadian Cardiovascular Society Angina Grading Scale.

Exclusion Criteria:

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

Sites / Locations

Taizhou Fourth People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dan-shen extract

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Serum level of Lp-PLA2

Secondary Outcome Measures

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

carotid arterial intima-media wall thickness

Canadian Cardiovascular Society (CCS) grading of angina pectoris

Change in the electrocardiogram (EKG)

Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate

Incidence of new-onset major vascular events

Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.

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.

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.

Full Information

NCT ID

NCT02870764

First Posted

August 13, 2016

Last Updated

September 11, 2016

Sponsor

Taizhou Fourth People's Hospital

Collaborators

Shanghai 10th People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02870764

Brief Title

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

Acronym

DOLPHIN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

May 2017 (Anticipated)

Study Completion Date

August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taizhou Fourth People's Hospital

Collaborators

Shanghai 10th People's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Angina, Stable, Inflammation

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dan-shen extract

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Dan-shen extract

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Other

Intervention Name(s)

Standard medical care

Intervention Description

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

Primary Outcome Measure Information:

Title

Serum level of Lp-PLA2

Time Frame

up to Day 60 after discharge

Secondary Outcome Measure Information:

Title

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

Time Frame

Day 0 and Day 60 after discharge

Title

carotid arterial intima-media wall thickness

Time Frame

Day0 and Day 60 after discharge

Title

Canadian Cardiovascular Society (CCS) grading of angina pectoris

Time Frame

Day 0 and Day 60 after discharge

Title

Change in the electrocardiogram (EKG)

Time Frame

Day 0 and Day 60 after discharge

Title

Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate

Time Frame

Day 0 and Day 60 after discharge

Title

Incidence of new-onset major vascular events

Description

Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.

Time Frame

up to 60 days after discharge

Title

Incidence of severe hemorrhages

Description

Time Frame

up to 60 days after discharge

Title

Incidence of moderate hemorrhages

Description

The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.

Time Frame

up to 60 days after discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chunling Wang, Bachelor

Phone

008613921709559

59201291@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

A'Di Chen, Master

Organizational Affiliation

Taizhou Fourth People's Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Taizhou Fourth People's Hospital

City

Taizhou

State/Province

Jiangsu

ZIP/Postal Code

225300

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bailing Su, MD

Phone

0086052380185012

tzsybgs055@sina.com

First Name & Middle Initial & Last Name & Degree

Haoshen Wang, MD

Phone

008613952613616

billet1116@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

We could provide individual participant data without leaking the patients' personal information if needed.

Citations:

PubMed Identifier

26654631

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.

Results Reference

background

PubMed Identifier

26489511

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.

Results Reference

background

PubMed Identifier

25585358

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. No abstract available.

Results Reference

background

PubMed Identifier

17363091

Citation

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.

Results Reference

background

PubMed Identifier

25879827

Citation

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.

Results Reference

background

PubMed Identifier

24152981

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.

Results Reference

background

PubMed Identifier

29262859

Citation

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.

Results Reference

derived

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

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