Angina, StablePhase 4DOLPHINNCT02870764
The Effect of Dan-shen Extract On Lipoprotein Associated PHospholipase A2 Levels IN Patients With Stable Angina Pectoris
A Phase 4 study testing Dan-shen extract and Standard medical care in people with Angina, Stable and Inflammation, run by Taizhou Fourth People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Angina, Stable, Inflammation
- What is being tested?
- Dan-shen extract and Standard medical care
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Taizhou Fourth People's Hospital
Taizhou, Jiangsu, 225300
Bailing Su, MD, 0086052380185012, tzsybgs055@sina.com
Haoshen Wang, MD, 008613952613616, billet1116@163.com
About this study
Official 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.
- Conditions
- Angina, Stable, Inflammation
- Being tested
- Dan-shen extract, Placebo, Standard medical care
- Keywords
- Danshenduofensuanyan, Lp-PLA2, coronary artery disease, Salvia miltiorrhiza
- Medical subject headings
- Angina, Stable, Inflammation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dan-shen extractDrug
Also called salvianolic acid, Depside salt from Salvia Miltiorrhiza, Danshen Dropping Pill, dropping salvia pill
A kind of injection made from a kind of Chinese herb: salvia miltiorrhiza
PlaceboDrug
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 careOther
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo; Other: Standard medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of Lp-PLA2
Measured: 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
Measured: Day 0 and Day 60 after discharge
carotid arterial intima-media wall thickness
Measured: Day0 and Day 60 after discharge
Canadian Cardiovascular Society (CCS) grading of angina pectoris
Measured: Day 0 and Day 60 after discharge
Change in the electrocardiogram (EKG)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 60 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Angina, StableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou Fourth People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 10th People's Hospital
- Responsible party
- Principal investigator, ChunLing Wang, Taizhou Fourth People's Hospital
- Investigators
- A'Di Chen, Master, Study chair, Taizhou Fourth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870764
- Sponsor's protocol ID
- TaizhouFPH-001
- Acronym
- DOLPHIN
- Status last verified
- Sep 2016
- First submitted
- 13 Aug 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: We could provide individual participant data without leaking the patients' personal information if needed.
Publications
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.
PubMed 26654631Wang 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.
PubMed 26489511Yao 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.
PubMed 25585358Cheng 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.
PubMed 17363091Cai 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.
PubMed 25879827White 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.
PubMed 24152981Chen 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.
PubMed 29262859
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial of Dan-shen Extract in Patients With Stable Angina Pectoris
- ClinicalTrials.gov ID
- NCT02870764
- Acronym / sponsor ID
- DOLPHIN / TaizhouFPH-001
- Conditions
- Angina, Stable, Inflammation
- Keywords
- Danshenduofensuanyan, Lp-PLA2, coronary artery disease, Salvia miltiorrhiza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Taizhou Fourth People's HospitalUniversity, hospital or other
- Collaborators
- Shanghai 10th People's Hospital
- Study start
- Sep 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dan-shen extract | Active comparator | Drug: Dan-shen extract, Other: Standard medical careBased 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 | Drug: Placebo, Other: Standard medical careBased 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dan-shen extractAlso: salvianolic acid, Depside salt from Salvia Miltiorrhiza, Danshen Dropping Pill, dropping salvia pillA kind of injection made from a kind of Chinese herb: salvia miltiorrhiza | Drug | Dan-shen extract |
| Placebo200mg 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. | Drug | Placebo |
| Standard medical careStandard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007). | Other | Dan-shen extract, Placebo |
Primary outcome
Serum level of Lp-PLA2
Time frame: up to Day 60 after discharge
8 secondary outcomes
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
carotid arterial intima-media wall thickness
Time frame: Day0 and Day 60 after discharge
Canadian Cardiovascular Society (CCS) grading of angina pectoris
Time frame: Day 0 and Day 60 after discharge
Change in the electrocardiogram (EKG)
Time frame: 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
Time frame: Day 0 and Day 60 after discharge
Incidence of new-onset major vascular events
Time frame: up to 60 days after discharge
Incidence of severe hemorrhages
Time frame: up to 60 days after discharge
Incidence of moderate hemorrhages
Time frame: up to 60 days after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Background: PubMed 26654631Li 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.
- Background: PubMed 26489511Wang 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.
- Background: PubMed 25585358Yao 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.
- Background: PubMed 17363091Cheng 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.
- Background: PubMed 25879827Cai 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.
- Background: PubMed 24152981White 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.
- Derived from this study: PubMed 29262859Chen 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.
- Individual participant dataSharing planned: Undecided. We could provide individual participant data without leaking the patients' personal information if needed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A'Di Chen, Master study chair
Taizhou Fourth People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dan-shen extract and Standard medical care in people with Angina, Stable and Inflammation, run by Taizhou Fourth People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunling Wang, Bachelor (008613921709559, 59201291@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum level of Lp-PLA2 (time frame: up to Day 60 after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02870764, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.