Coronary Artery StenosisPhase 4NCT01513070

A Clinical Trials of Quick-Acting Heart Reliever for Moderate Coronary Stenosis

A Phase 4 study testing Quick-Acting Heart Reliever, Isosorbide Dinitrate and Aspirin Enteric-coated Tablets in people with Coronary Artery Stenosis and Coronary Heart Disease, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 75 years
Conditions the study is for: Coronary Artery Stenosis, Coronary Heart Disease
What is being tested?: Quick-Acting Heart Reliever, Isosorbide Dinitrate and Aspirin Enteric-coated Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteChina
Study dates: Apr 2012to Jun 2014
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 30 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects 30-75 years of age
Angina or CAD patient
Diameter stenosis 50-75% in at least one main coronary artery (Confirmed by coronary arteriography or coronary CT angiography)
Not received percutaneous coronary intervention(PCI)
Heart blood stasis obstruction syndrome according to TCM syndrome differentiation
Provide written informed consent.

Who cannot join

Heart transplant or history of CABG or history of percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent.
Left ventricular ejection fraction < 35%
Acute myocardial infarction within 4 weeks prior to inclusion
The contractive pressure > 160 mmHg or diastolic pressure >100 mmHg
Severe valvular heart disease
Insulin-dependent diabetes mellitus

Show all 14Show fewer

Serious heart, lung, liver, kidney and brain or other primary complications
Mental patients
Diagnosed or suspected tumor
Allergic persons
Pregnant, breastfeeding, or intends to become pregnant during the course of the study (females only)
Patients not willing to or not able to give the informed consent to participate in the study
The patients who are attending other clinical trial
The person maybe loss for some reason such as work or life condition according to the investigator's judgement

Trial locations and contacts

1 site in 1 country.

China1 site

Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053

Other trials in China

About this study

Official title: A Randomized Double-blind Placebo-controlled Clinical Trials of the Blood-quickening Stasis-transforming Formula Quick-Acting Heart Reliever for Patients With Moderate Coronary Stenosis

This study investigates the effective power of angina pectoris after Quick-Acting Heart Reliever and isosorbide dinitrate interventing respectively the patients with moderate coronary stenosis for six months. At the same time, the studying will assess the plaque, myocardial blood-supplying,quality of life and observe the end point of the heart (including the myocardial revascularization, death and myocardial infarction). The purpose is to study the function of the blood-quickening stasis-transforming formula Quick-Acting Heart Reliever for moderate coronary stenosis lesions.

Read the detailed description

Blood-quickening stasis-transforming medicinal of Chinese medicinal can ameliorate clinical symptoms of coronary artery disease. Quick-Acting Heart Reliever is one of blood-quickening stasis-transforming medicinals to relieve angina pectoris in clinic and is especially benefit for the patients with moderate coronary stenosis who need not coronary revascularization only have medical treatment. But there is no randomized evidence that established the beneficial effects of blood-quickening stasis-transforming medicinals to treat moderate coronary stenosis lesions. This study is a randomized double-blind placebo-controlled clinical trials. A total of 120 consecutive participants with at least one moderate coronary stenosis lesion (diameter stenosis 50-75%) will be randomized to two groups: group 1(n =60) will receive Quick-Acting Heart and the placebo of isosorbide dinitrate, patients in group 2(n = 60) will receive isosorbide dinitrate and the placebo of Quick-Acting Heart for six months. The myocardial perfusion imaging and the coronary CT angiography will be used to evaluate the effective power of angina pectoris,myocardial blood-supplying，the quality and volume of the plaque, diameter stenosis after treating after 6 months and the end point of the heart (including death，myocardial infarction and myocardial revascularization which includes intracoronary stenting and coronary artery bypass grafting,) after 12 months. The purpose is to study the function of Quick-Acting Heart Reliever delaying percutaneous coronary intervention(PCI) for moderate coronary stenosis.

Conditions: Coronary Artery Stenosis, Coronary Heart Disease
Being tested: Quick-Acting Heart Reliever, Isosorbide Dinitrate, Placebo of Isosorbide Dinitrate, Aspirin Enteric-coated Tablets, Placebo of Quick-Acting Heart Reliever
Keywords: Quick-Acting Heart Reliever, Coronary Artery Stenosis, Coronary Heart Disease, Suxiao Jiuxin Pill, Chinese Herbal Drugs, Traditional Chinese Medicine, Chinese Medicine, Angina Pectoris, Isosorbide Dinitrate, Myocardial Perfusion Imaging, Clinical Trial
Medical subject headings: Coronary Stenosis, Coronary Disease, Angina Pectoris

What participants receive

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

Quick-Acting Heart RelieverDrug
Also called Suxiao Jiuxin Pill
Quick-Acting Heart Reliever，200mg，tid，po. for six months
Isosorbide DinitrateDrug
Also called Cedocard，Nitrosorbide， Vascardin
Isosorbide Dinitrate，10mg，tid，po. for six months
Placebo of Isosorbide DinitrateDrug
Placebo of Isosorbide Dinitrate，10mg，tid，po. for six months
Aspirin Enteric-coated TabletsDrug
Aspirin Enteric-coated Tablets，100mg，qd，po. for six months
Placebo of Quick-Acting Heart RelieverDrug
Placebo of Quick-Acting Heart Reliever，200mg，tid，po. for six months
Aspirin Enteric-coated TabletsDrug
Aspirin Enteric-coated Tablets，100mg，qd，po. for six months

Study groups in NCT01513070
Study group	Role	What they receive
Quick-Acting Heart Reliever group	Experimental	Drug: Quick-Acting Heart Reliever and Placebo of isosorbide dinitrate and Aspirin Enteric-coated Tablets Receives: Drug: Quick-Acting Heart Reliever; Drug: Placebo of Isosorbide Dinitrate; Drug: Aspirin Enteric-coated Tablets
Isosorbide Dinitrate group	Active comparator	Isosorbide Dinitrate and Placebo of Quick-Acting Heart Reliever and Aspirin Enteric-coated Tablets Receives: Drug: Isosorbide Dinitrate; Drug: Placebo of Quick-Acting Heart Reliever; Drug: Aspirin Enteric-coated Tablets

What is being measured

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

the effective power of angina pectoris
the effective power of angina pectoris after Quick-Acting Heart Reliever and isosorbide dinitrate interventing respectively the patients with morderate coronary stenosis for six months
Measured: 6 months

Secondary outcomes (9)

plaque
Assess the plaque by the coronary CT angiography
Measured: 6 months
myocardium blood-supply
Evaluate the myocardium blood-supply by the myocardial perfusion imaging
Measured: 6 months
the end point of the heart(a composite of cardiovascular events including death, nonfatal myocardial infarction,coronary revascularization, hospitalized unstable angina)
Measured: 12 months
symptoms score
Measured: 6 months
quality of life
Measured: 6 months
MMP-9
Measured: 6 months
SCD40L
Measured: 6 months
VEGF
Measured: 6 months
bFGF
Measured: 6 months

Timeline

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

Apr 2012Jun 2014

First posted20 Jan 2012 (estimated)
Study startApr 2012
Primary completionJul 2012
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Coronary Artery StenosisStudies 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: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01513070
Sponsor's protocol ID: SUXIAOJIUXIN2010
Status last verified: Aug 2014
First submitted: 16 Jan 2012
Last updated: 5 Aug 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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?

See locations

Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Recruiting
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Renovascular Hypertension, Renovascular Hypertension With Renal Failure

All Coronary Artery Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Double-blind Placebo-controlled Clinical Trials of the Blood-quickening Stasis-transforming Formula Quick-Acting Heart Reliever for Patients With Moderate Coronary Stenosis
ClinicalTrials.gov ID: NCT01513070
Acronym / sponsor ID: SUXIAOJIUXIN2010
Conditions: Coronary Artery Stenosis, Coronary Heart Disease
Keywords: Quick-Acting Heart Reliever, Coronary Artery Stenosis, Coronary Heart Disease, Suxiao Jiuxin Pill, Chinese Herbal Drugs, Traditional Chinese Medicine, Chinese Medicine, Angina Pectoris
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (estimated)
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
Study start: Apr 2012
Primary completion: Jul 2012 (actual)
Study completion: Jun 2014 (actual)
First posted: 20 Jan 2012 (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.

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
Quick-Acting Heart Reliever group	Experimental	Drug: Quick-Acting Heart Reliever, Drug: Placebo of Isosorbide Dinitrate, Drug: Aspirin Enteric-coated TabletsDrug: Quick-Acting Heart Reliever and Placebo of isosorbide dinitrate and Aspirin Enteric-coated Tablets
Isosorbide Dinitrate group	Active comparator	Drug: Isosorbide Dinitrate, Drug: Placebo of Quick-Acting Heart Reliever, Drug: Aspirin Enteric-coated TabletsIsosorbide Dinitrate and Placebo of Quick-Acting Heart Reliever and Aspirin Enteric-coated Tablets

Who may qualify

Ages: 30 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male or female subjects 30-75 years of age
Angina or CAD patient
Diameter stenosis 50-75% in at least one main coronary artery (Confirmed by coronary arteriography or coronary CT angiography)
Not received percutaneous coronary intervention(PCI)
Heart blood stasis obstruction syndrome according to TCM syndrome differentiation

Key exclusion criteria (14 listed)

Heart transplant or history of CABG or history of percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent.
Left ventricular ejection fraction < 35%
Acute myocardial infarction within 4 weeks prior to inclusion
The contractive pressure > 160 mmHg or diastolic pressure >100 mmHg
Severe valvular heart disease

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
Quick-Acting Heart RelieverAlso: Suxiao Jiuxin PillQuick-Acting Heart Reliever，200mg，tid，po. for six months	Drug	Quick-Acting Heart Reliever group
Isosorbide DinitrateAlso: Cedocard，Nitrosorbide， VascardinIsosorbide Dinitrate，10mg，tid，po. for six months	Drug	Isosorbide Dinitrate group
Placebo of Isosorbide DinitratePlacebo of Isosorbide Dinitrate，10mg，tid，po. for six months	Drug	Quick-Acting Heart Reliever group
Aspirin Enteric-coated TabletsAspirin Enteric-coated Tablets，100mg，qd，po. for six months	Drug	Quick-Acting Heart Reliever group
Placebo of Quick-Acting Heart RelieverPlacebo of Quick-Acting Heart Reliever，200mg，tid，po. for six months	Drug	Isosorbide Dinitrate group
Aspirin Enteric-coated TabletsAspirin Enteric-coated Tablets，100mg，qd，po. for six months	Drug	Isosorbide Dinitrate group

Primary outcome

the effective power of angina pectoris
Time frame: 6 months
the effective power of angina pectoris after Quick-Acting Heart Reliever and isosorbide dinitrate interventing respectively the patients with morderate coronary stenosis for six months

9 secondary outcomes

plaque
Time frame: 6 months
myocardium blood-supply
Time frame: 6 months
the end point of the heart(a composite of cardiovascular events including death, nonfatal myocardial infarction,coronary revascularization, hospitalized unstable angina)
Time frame: 12 months
symptoms score
Time frame: 6 months
quality of life
Time frame: 6 months
MMP-9
Time frame: 6 months
SCD40L
Time frame: 6 months
VEGF
Time frame: 6 months
bFGF
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.

Related trials for Coronary Artery Stenosis

Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Recruiting
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Renovascular Hypertension, Renovascular Hypertension With Renal Failure

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.

Jie Wang, MD study chair

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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: finished, as of the sponsor's last update on 5 Aug 2014. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the effective power of angina pectoris (time frame: 6 months). 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 NCT01513070.

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 5 Aug 2014.