Inflammation Clinical Trial
— DOLPHINOfficial title:
A Randomized, Double-blind, Placebo-controlled Trial of Dan-shen Extract in Patients With Stable Angina Pectoris
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Taizhou Fourth People's Hospital | Taizhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Taizhou Fourth People's Hospital | Shanghai 10th People's Hospital |
China,
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
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 |
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