Coronary Artery Disease(CAD)Phase 4NCT03072082

Curative Effect Evaluation of Danlou Tablet on Coronary Artery Disease Not Amenable to Revascularization

A Phase 4 study testing Danlou Tablet, Aspirin Enteric-coated Tablets and Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet in people with Coronary Artery Disease(CAD), run by Jun Li.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The purpose of this study is to determine whether Danlou Tablet is effective in the treatment of coronary artery disease not amenable to revascularization on the basis of western medicine therapy. Read more about this study

Who is it for?: Ages 45 to 75 years
Conditions the study is for: Coronary Artery Disease(CAD)
What is being tested?: Danlou Tablet, Aspirin Enteric-coated Tablets and Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 440 participants
Where: No sites listed yet
Study dates: Jun 2017to Feb 2019
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 45 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants are aged between 45 and 75 years, diagnosed with sever CAD through coronary arteriography which shows that the left main coronary artery and three-vessel have sever diffuse stenosis, calcification or vascular ectasia, be in accordance with Traditional Chinese Medicine syndrome of "Qi deficiency and blood stasis syndrome" or "phlegm and stasis mu-tual obstruction syndrome".

Who cannot join

Patients with severe valvular disease, congenital cardiomyopathy decompensation
Patients with CAD complicated with severe multiple organ disease such as severe heart failure, severe lung, liver or renal dysfunction, peptic ulcer in active stage, or intracranial hemorrhage
Patients that use high-dose steroids due to connective tissue disease
Patients with serious infections
Patients with malignant tumor
Patients with hematopoietic diseases
Pregnant or lactating women.

Trial locations and contacts

No sites are listed yet.

Jun Li, MD contact

Panpan Tian contact

About this study

Official title: Study of Curative Effect Evaluation of DanLou Tablet on Coronary Artery Disease Not Amenable to Revascularization on the Basis of Western Medicine Therapy

The purpose of this study is to determine whether Danlou Tablet is effective in the treatment of coronary artery disease not amenable to revascularization on the basis of western medicine therapy.

Read the detailed description

The western medicine treatment for CAD not amenable to revascularization is limited. Danlou Tablet, a kind of Chinese patent medicine has been used for treating coronary artery disease in clinical practice in China for many years.

Danlou Tablet is applicable to "phlegm-stasis syndrome" in Traditional Chinese Medicine. According to recent studies, Danlou Tablet can reduce blood lipid level and myocardial necrosis area ,promote infarct healing in rats.And it can improve clinical symptoms of patients with CAD.

Conditions: Coronary Artery Disease(CAD)
Being tested: Danlou Tablet, DanLou Tablet placebo, Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin calcium
Keywords: coronary artery disease, revascularization, Danlou Tablet
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Danlou TabletDrug
Conventional western medicine \& Danlou Tablet
DanLou Tablet placeboDrug
Conventional western medicine \& placebo (for Danlou Tablet)
Aspirin Enteric-coated TabletsDrug
100 mg tablet, one tablet daily.
Clopidogrel Hydrogen Sulfate 75 MG Oral TabletDrug
Also called Plavix
One tablet daily. (for patients who can't use aspirin)
Atorvastatin calciumDrug
Also called Lipitor
10 mg tablet, two tablets each night.
Isosorbide Mononitrate Tab 20 MGDrug
Also called Xinkang
One tablet two times daily.
Metoprolol Tartrate Tab 25 MGDrug
Also called Metoprolol
12.5 mg or 25 mg two times daily.
Trimetazidine Dihydrochloride TabletsDrug
Also called Vasorel
20 mg tablet, one tablet three times daily.

Study groups in NCT03072082
Study group	Role	What they receive
Danlou Tablet	Experimental	Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months \& conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets) Receives: Drug: Danlou Tablet; Drug: Aspirin Enteric-coated Tablets; Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet; Drug: Atorvastatin calcium; Drug: Isosorbide Mononitrate Tab 20 MG; Drug: Metoprolol Tartrate Tab 25 MG; Drug: Trimetazidine Dihydrochloride Tablets
Danlou Tablet placebo	Placebo comparator	Placebo Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months \& conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets) Receives: Drug: DanLou Tablet placebo; Drug: Aspirin Enteric-coated Tablets; Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet; Drug: Atorvastatin calcium; Drug: Isosorbide Mononitrate Tab 20 MG; Drug: Metoprolol Tartrate Tab 25 MG; Drug: Trimetazidine Dihydrochloride Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Mortality
Death caused by cardiovascular disease
Measured: Six months after randomisation

Secondary outcomes (5)

Ejection fraction percentage (EF%)
One of Echocardiographic parameters
Measured: At baseline (before randomisation), and six months after randomisation
E/A ratio
One of Echocardiographic parameters
Measured: At baseline (before randomisation), and six months after randomisation
C-reactive protein (CRP)
CRP in μg/L
Measured: At baseline (before randomisation), and six months after randomisation.
B-type natriuretic peptide (BNP)
BNP in pg/mL
Measured: At baseline (before randomisation), and six months after randomisation.
Hospital readmission rates
Hospital readmission rates due to coronary artery disease during treatment
Measured: At baseline (before randomisation), and six months after randomisation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2017Feb 2019

First posted7 Mar 2017
Study startJun 2017 (estimated)
Primary completionDec 2018 (estimated)
Study completionFeb 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Coronary Artery Disease(CAD)Studies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 440 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03072082
Sponsor's protocol ID: DLT-2016
Status last verified: Mar 2017
First submitted: 22 Feb 2017
Last updated: 4 Apr 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Zhao D. [Why dentists need to learn the epidemiological status and prevention strategy of coronary heart disease in China]. Zhonghua Kou Qiang Yi Xue Za Zhi. 2016 Jul;51(7):385-6. doi: 10.3760/cma.j.issn.1002-0098.2016.07.001. Chinese.
PubMed 27480425
Zhu H, Luo XP, Wang LJ. [Evaluation on clinical effect of long-term shexiang baoxin pill administration for treatment of coronary heart disease]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2010 May;30(5):474-7. Chinese.
PubMed 20681275
Zhou Z, Shen W, Yu L, Xu C, Wu Q. A Chinese patent medicine, Shexiang Baoxin Pill, for Non-ST-elevation acute coronary syndromes: A systematic review. J Ethnopharmacol. 2016 Dec 24;194:1130-1139. doi: 10.1016/j.jep.2016.11.024. Epub 2016 Nov 12.
PubMed 27847338
Williams B, Menon M, Satran D, Hayward D, Hodges JS, Burke MN, Johnson RK, Poulose AK, Traverse JH, Henry TD. Patients with coronary artery disease not amenable to traditional revascularization: prevalence and 3-year mortality. Catheter Cardiovasc Interv. 2010 May 1;75(6):886-91. doi: 10.1002/ccd.22431.
PubMed 20432394
Gupta S, Pressman GS, Morris DL, Figueredo VM. Distribution of left ventricular ejection fraction in angina patients with severe coronary artery disease not amenable to revascularization. Coron Artery Dis. 2010 Aug;21(5):278-80. doi: 10.1097/MCA.0b013e32833bdf53.
PubMed 20531008
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
PubMed 23303884
Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.
PubMed 22019563
Wang L, Mao S, Qi JY, Ren Y, Guo XF, Chen KJ, Zhang MZ. Effect of Danlou Tablet () on peri-procedural myocardial injury among patients undergoing percutaneous coronary intervention for non-ST elevation acute coronary syndrome: A study protocol of a multicenter, randomized, controlled trial. Chin J Integr Med. 2015 Sep;21(9):662-6. doi: 10.1007/s11655-015-2284-1. Epub 2015 Jul 4.
PubMed 26142341
Wang SH, Wang J, Li J. [Efficacy assessment of treating patients with coronary heart disease angina of phlegm and stasis mutual obstruction syndrome by Danlou tablet]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2012 Aug;32(8):1051-5. Chinese.
PubMed 23173251
Chen J, Cai HW, Miao J, Xu XM, Mao W. [Danlou Tablet Fought against Inflammatory Reaction in Atherosclerosis Rats with Intermingled Phlegm and Blood Stasis Syndrome and Its Mechanism Study]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2016 Jun;36(6):703-8. Chinese.
PubMed 27491230

Want to know more?

Jun Li, MD

+86 13051458913

13051458913@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Coronary Artery Disease(CAD) trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Curative Effect Evaluation of DanLou Tablet on Coronary Artery Disease Not Amenable to Revascularization on the Basis of Western Medicine Therapy
ClinicalTrials.gov ID: NCT03072082
Acronym / sponsor ID: DLT-2016
Conditions: Coronary Artery Disease(CAD)
Keywords: coronary artery disease, revascularization, Danlou Tablet
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 440 participants (estimated)
Lead sponsor: Jun LiUniversity, hospital or other
Collaborators: China Academy of Chinese Medical Sciences
Study start: Jun 2017 (estimated)
Primary completion: Dec 2018 (estimated)
Study completion: Feb 2019 (estimated)
First posted: 7 Mar 2017 (actual)
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.

The purpose of this study is to determine whether Danlou Tablet is effective in the treatment of coronary artery disease not amenable to revascularization on the basis of western medicine therapy.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Danlou Tablet	Experimental	Drug: Danlou Tablet, Drug: Aspirin Enteric-coated Tablets, Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Drug: Atorvastatin calcium, Drug: Isosorbide Mononitrate Tab 20 MG, Drug: Metoprolol Tartrate Tab 25 MG, Drug: Trimetazidine Dihydrochloride TabletsDanlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months \& conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
Danlou Tablet placebo	Placebo comparator	Drug: DanLou Tablet placebo, Drug: Aspirin Enteric-coated Tablets, Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Drug: Atorvastatin calcium, Drug: Isosorbide Mononitrate Tab 20 MG, Drug: Metoprolol Tartrate Tab 25 MG, Drug: Trimetazidine Dihydrochloride TabletsPlacebo Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months \& conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)

Who may qualify

Ages: 45 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Participants are aged between 45 and 75 years, diagnosed with sever CAD through coronary arteriography which shows that the left main coronary artery and three-vessel have sever diffuse stenosis, calcification or vascular ectasia, be in accordance with Traditional Chinese Medicine syndrome of "Qi deficiency and blood stasis syndrome" or "phlegm and stasis mu-tual obstruction syndrome".

Key exclusion criteria (7 listed)

Patients with severe valvular disease, congenital cardiomyopathy decompensation
Patients with CAD complicated with severe multiple organ disease such as severe heart failure, severe lung, liver or renal dysfunction, peptic ulcer in active stage, or intracranial hemorrhage
Patients that use high-dose steroids due to connective tissue disease
Patients with serious infections
Patients with malignant tumor

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
Danlou TabletConventional western medicine \& Danlou Tablet	Drug	Danlou Tablet
DanLou Tablet placeboConventional western medicine \& placebo (for Danlou Tablet)	Drug	Danlou Tablet placebo
Aspirin Enteric-coated Tablets100 mg tablet, one tablet daily.	Drug	Danlou Tablet, Danlou Tablet placebo
Clopidogrel Hydrogen Sulfate 75 MG Oral TabletAlso: PlavixOne tablet daily. (for patients who can't use aspirin)	Drug	Danlou Tablet, Danlou Tablet placebo
Atorvastatin calciumAlso: Lipitor10 mg tablet, two tablets each night.	Drug	Danlou Tablet, Danlou Tablet placebo
Isosorbide Mononitrate Tab 20 MGAlso: XinkangOne tablet two times daily.	Drug	Danlou Tablet, Danlou Tablet placebo
Metoprolol Tartrate Tab 25 MGAlso: Metoprolol12.5 mg or 25 mg two times daily.	Drug	Danlou Tablet, Danlou Tablet placebo
Trimetazidine Dihydrochloride TabletsAlso: Vasorel20 mg tablet, one tablet three times daily.	Drug	Danlou Tablet, Danlou Tablet placebo

Primary outcome

Mortality
Time frame: Six months after randomisation
Death caused by cardiovascular disease

5 secondary outcomes

Ejection fraction percentage (EF%)
Time frame: At baseline (before randomisation), and six months after randomisation
E/A ratio
Time frame: At baseline (before randomisation), and six months after randomisation
C-reactive protein (CRP)
Time frame: At baseline (before randomisation), and six months after randomisation.
B-type natriuretic peptide (BNP)
Time frame: At baseline (before randomisation), and six months after randomisation.
Hospital readmission rates
Time frame: At baseline (before randomisation), and six months after randomisation.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
Results publication: PubMed 27480425Zhao D. [Why dentists need to learn the epidemiological status and prevention strategy of coronary heart disease in China]. Zhonghua Kou Qiang Yi Xue Za Zhi. 2016 Jul;51(7):385-6. doi: 10.3760/cma.j.issn.1002-0098.2016.07.001. Chinese.
Results publication: PubMed 20681275Zhu H, Luo XP, Wang LJ. [Evaluation on clinical effect of long-term shexiang baoxin pill administration for treatment of coronary heart disease]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2010 May;30(5):474-7. Chinese.
Results publication: PubMed 27847338Zhou Z, Shen W, Yu L, Xu C, Wu Q. A Chinese patent medicine, Shexiang Baoxin Pill, for Non-ST-elevation acute coronary syndromes: A systematic review. J Ethnopharmacol. 2016 Dec 24;194:1130-1139. doi: 10.1016/j.jep.2016.11.024. Epub 2016 Nov 12.
Results publication: PubMed 20432394Williams B, Menon M, Satran D, Hayward D, Hodges JS, Burke MN, Johnson RK, Poulose AK, Traverse JH, Henry TD. Patients with coronary artery disease not amenable to traditional revascularization: prevalence and 3-year mortality. Catheter Cardiovasc Interv. 2010 May 1;75(6):886-91. doi: 10.1002/ccd.22431.
Results publication: PubMed 20531008Gupta S, Pressman GS, Morris DL, Figueredo VM. Distribution of left ventricular ejection fraction in angina patients with severe coronary artery disease not amenable to revascularization. Coron Artery Dis. 2010 Aug;21(5):278-80. doi: 10.1097/MCA.0b013e32833bdf53.
Results publication: PubMed 23303884Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
Results publication: PubMed 22019563Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.
Results publication: PubMed 26142341Wang L, Mao S, Qi JY, Ren Y, Guo XF, Chen KJ, Zhang MZ. Effect of Danlou Tablet () on peri-procedural myocardial injury among patients undergoing percutaneous coronary intervention for non-ST elevation acute coronary syndrome: A study protocol of a multicenter, randomized, controlled trial. Chin J Integr Med. 2015 Sep;21(9):662-6. doi: 10.1007/s11655-015-2284-1. Epub 2015 Jul 4.
Results publication: PubMed 23173251Wang SH, Wang J, Li J. [Efficacy assessment of treating patients with coronary heart disease angina of phlegm and stasis mutual obstruction syndrome by Danlou tablet]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2012 Aug;32(8):1051-5. Chinese.
Results publication: PubMed 27491230Chen J, Cai HW, Miao J, Xu XM, Mao W. [Danlou Tablet Fought against Inflammatory Reaction in Atherosclerosis Rats with Intermingled Phlegm and Blood Stasis Syndrome and Its Mechanism Study]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2016 Jun;36(6):703-8. Chinese.
Individual participant dataSharing planned: Undecided

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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.

Jun Li, MD contact

Panpan Tian contact

Jie Wang, MD study director

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Danlou Tablet, Aspirin Enteric-coated Tablets and Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet in people with Coronary Artery Disease(CAD), run by Jun Li.

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 1 inclusion and 7 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

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 Jun Li, MD (+86 13051458913, 13051458913@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: Six months after randomisation). 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 NCT03072082, which also lists 10 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 4 Apr 2017.