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

Sponsor

Taizhou Fourth People's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02870764

Collaborator

Shanghai 10th People's Hospital (Other)

156

Enrollment

Location

Arms

Duration (Months)

14.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Angina, Stable Inflammation	Drug: Dan-shen extract Drug: Placebo Other: Standard medical care	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

May 1, 2017

Anticipated Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Dan-shen extract A kind of injection made from a kind of Chinese herb: salvia miltiorrhiza Other Names: salvianolic acid Depside salt from Salvia Miltiorrhiza Danshen Dropping Pill dropping salvia pill Other: Standard medical care Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).
Placebo Comparator: 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.	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. Other: Standard medical care Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Dan-shen extract

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

Other Names:

salvianolic acid

Depside salt from Salvia Miltiorrhiza

Danshen Dropping Pill

dropping salvia pill

Other: Standard medical care

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

Placebo Comparator: 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.

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.

Other: Standard medical care

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

Outcome Measures

Primary Outcome Measures

Serum level of Lp-PLA2 [up to Day 60 after discharge]

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 [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]
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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:
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