Coronary Artery DiseasePhase 4TalentNCT01721590
Tongxinluo Improve High on Clopidogrel Platelet Reactivity Patients With Coronary Heart Disease
A Phase 4 study testing Tongxinluo in people with Coronary Artery Disease, run by Han Yaling at 3 sites in China.
Trial summary
Tongxinluo is a kind of Chinese patent drug,which could promote blood circulation.Recent reports suggested that tongxinluo's effectiveness in reducing the thrombin activity.In this prospective randomized study,all patients in control group will receive blank placebo ,all patients in test group will receive… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Tongxinluo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 3 sitesChina
- Study dates
- Nov 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1)ACS (including unstable angina pectoris, non-ST-segment elevation myocardial infarction and ST-elevation myocardial infarction) （2）Accept at least one coronary stent. （3）The age between18 and 75 . （4）High on-treatment platelet reactivity defined as an ADP-induced platelet aggregation (by VerifyNow，PRU≥236）at 24 hr after clopidogrel loading (300 ~ 600mg)or 24 hours after PCI.
- （5）Informed Consent
Who cannot join
- （1）Tongxinluo contraindication . （2）Receiving GP IIb / IIIa receptor antagonist treatment （3）Who complicate the known bleeding tendency and blood system diseases. （4）NYHA grade III ~ IV （5）Aspirin or clopidogrel allergies （6）Severe liver or kidney dysfunction （7）Pregnancy （8）Cann't accept 30 days supervision and blood proofer. （9）Other serious illness, life expectancy less than 6 months. （10) Planned surgery recently （11) PCI again within 30 days. (12) Mental diseases interfering understanding the informed consent form （13）Accept other drugs or participate in other clinical research at the same time .
Trial locations and contacts
3 sites in 1 country.
China3 sites
ShenZhou Hopital Of ShenYang Medical College
ShengYang, Liaoning, 110032
The 463th Hospital Of PLA
Shenyang, Liaoning, 110042
Northern Hospital
Shenyang, Liaoning
About this study
Official title: Study of Tongxinluo to Improve High on Clopidogrel Platelet Reactivity in Patients With Coronary Heart Disease
Tongxinluo is a kind of Chinese patent drug,which could promote blood circulation.Recent reports suggested that tongxinluo's effectiveness in reducing the thrombin activity.In this prospective randomized study,all patients in control group will receive blank placebo ,all patients in test group will receive tongxinluo.All patients will be followed up for one year.
Read the detailed description
The primary endpoint is Platelet Reaction Unit( by VerifyNow) at 30 days.The secondary endpoints include inflammation marker (hsCRP、CD62P-CD41),TT,FIB and PT at 30 days,and MI、Ischemic Stroke, target vessel revascularization and all-cause mortality 、bleeding events at 1 year.
- Conditions
- Coronary Artery Disease
- Being tested
- Tongxinluo, placebo
- Keywords
- high on-treatment platelet reactivity, Coronary Heart Disease, Tongxinluo
- Medical subject headings
- Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TongxinluoDrug
Also called Tongxinluo capsule
Tongxinluo,3 capsules/time 3times/day for 1 year
placeboDrug
Also called placebo capsules
3 capsules/time，3times/day for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo，3 capsules/time，3times/day for 1 year Receives: Drug: placebo |
| Tongxinluo | Experimental | Tongxinluo 3 capsules/time 3times/day for 1 year Receives: Drug: Tongxinluo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reaction unit(PRU) measured by verifyNow
to measure the rate of HPR(PRU ≤ 235)
Measured: 1 month
Secondary outcomes (10)
Inflammation Marker (hsCRP、CD62P-CD41)
Measured: 1 month
Plasma fibrinogen concentration
Measured: 1 month
Thrombin time
Measured: 1 month
Prothrombin time
Measured: 1 month
major adverse cardiovascular events
Including MI,Stroke,target vessel revascularization,and all-cause mortality
Measured: 1 year
bleeding event
Measured: 1 year
Adverse drug reaction and withdrawal rate
Measured: 1 month ，1 year
Angina recurrence
Measured: 1 year
Traditional Chinese medicine angina symptoms scores
Measured: 1 year
Intra-stent thrombosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- 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 DiseaseStudies 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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Han Yaling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Han Yaling, Shenyang Northern Hospital
- Investigators
- Yaling Han, Dr, Principal investigator, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721590
- Sponsor's protocol ID
- SYNH-20120929
- Acronym
- Talent
- Status last verified
- Dec 2015
- First submitted
- 1 Nov 2012
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Tongxinluo to Improve High on Clopidogrel Platelet Reactivity in Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT01721590
- Acronym / sponsor ID
- Talent / SYNH-20120929
- Conditions
- Coronary Artery Disease
- Keywords
- high on-treatment platelet reactivity, Coronary Heart Disease, Tongxinluo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Han YalingUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Nov 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.
Tongxinluo is a kind of Chinese patent drug,which could promote blood circulation.Recent reports suggested that tongxinluo's effectiveness in reducing the thrombin activity.In this prospective randomized study,all patients in control group will receive blank placebo ,all patients in test group will receive tongxinluo.All patients will be followed up for one year.
Detailed description
The primary endpoint is Platelet Reaction Unit( by VerifyNow) at 30 days.The secondary endpoints include inflammation marker (hsCRP、CD62P-CD41),TT,FIB and PT at 30 days,and MI、Ischemic Stroke, target vessel revascularization and all-cause mortality 、bleeding events at 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: placeboPlacebo，3 capsules/time，3times/day for 1 year |
| Tongxinluo | Experimental | Drug: TongxinluoTongxinluo 3 capsules/time 3times/day for 1 year |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (1)ACS (including unstable angina pectoris, non-ST-segment elevation myocardial infarction and ST-elevation myocardial infarction) （2）Accept at least one coronary stent. （3）The age between18 and 75 . （4）High on-treatment platelet reactivity defined as an ADP-induced platelet aggregation (by VerifyNow，PRU≥236）at 24 hr after clopidogrel loading (300 ~ 600mg)or 24 hours after PCI.
- （5）Informed Consent
Key exclusion criteria (1 listed)
- （1）Tongxinluo contraindication . （2）Receiving GP IIb / IIIa receptor antagonist treatment （3）Who complicate the known bleeding tendency and blood system diseases. （4）NYHA grade III ~ IV （5）Aspirin or clopidogrel allergies （6）Severe liver or kidney dysfunction （7）Pregnancy （8）Cann't accept 30 days supervision and blood proofer. （9）Other serious illness, life expectancy less than 6 months. （10) Planned surgery recently （11) PCI again within 30 days. (12) Mental diseases interfering understanding the informed consent form （13）Accept other drugs or participate in other clinical research at the same time .
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 |
|---|---|---|
| TongxinluoAlso: Tongxinluo capsuleTongxinluo,3 capsules/time 3times/day for 1 year | Drug | Tongxinluo |
| placeboAlso: placebo capsules3 capsules/time，3times/day for 1 year | Drug | Control |
Primary outcome
Platelet reaction unit(PRU) measured by verifyNow
Time frame: 1 month
to measure the rate of HPR(PRU ≤ 235)
10 secondary outcomes
Inflammation Marker (hsCRP、CD62P-CD41)
Time frame: 1 month
Plasma fibrinogen concentration
Time frame: 1 month
Thrombin time
Time frame: 1 month
Prothrombin time
Time frame: 1 month
major adverse cardiovascular events
Time frame: 1 year
bleeding event
Time frame: 1 year
Adverse drug reaction and withdrawal rate
Time frame: 1 month ，1 year
Angina recurrence
Time frame: 1 year
Traditional Chinese medicine angina symptoms scores
Time frame: 1 year
Intra-stent thrombosis
Time frame: 1 year
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 23 Dec 2015.
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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.
Yaling Han, Dr principal investigator
Shenyang Northern Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tongxinluo in people with Coronary Artery Disease, run by Han Yaling at 3 sites 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 2 inclusion and 1 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 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Platelet reaction unit(PRU) measured by verifyNow (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2015.