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| Name | Class |
|---|---|
| Shanghai 10th People's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dan-shen extract | Drug | A kind of injection made from a kind of Chinese herb: salvia miltiorrhiza |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum level of Lp-PLA2 | up to Day 60 after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Patients with moderate angina pectoris, which is defined as Grade II or III on the Canadian Cardiovascular Society Angina Grading Scale.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunling Wang, Bachelor | Contact | 008613921709559 | 59201291@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| A'Di Chen, Master | Taizhou Fourth People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taizhou Fourth People's Hospital | Recruiting | Taizhou | Jiangsu | 225300 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26654631 | Background | 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. | |
| 26489511 | 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. |
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We could provide individual participant data without leaking the patients' personal information if needed.
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D007249 | Inflammation |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C028972 | dan-shen root extract |
| C568740 | salvianolic acid |
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| 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. |
|
| Standard medical care | Other | Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007). |
|
| 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 | Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death. | up to 60 days after discharge |
| 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 |
| 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 |
| 25585358 | 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. |
| 17363091 | 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. |
| 25879827 | 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. |
| 24152981 | 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. |
| 29262859 | Derived | 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. |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |