MedDataX Logo

Tongxinluo Improve High on Clopidogrel Platelet Reactivity Patients With Coronary Heart Disease

NCT ID: NCT01721590

Last Updated: 2015-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

high on-treatment platelet reactivity Coronary Heart Disease Tongxinluo

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Placebo，3 capsules/time，3times/day for 1 year

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

3 capsules/time，3times/day for 1 year

Tongxinluo

Tongxinluo 3 capsules/time 3times/day for 1 year

Group Type EXPERIMENTAL

Tongxinluo

Intervention Type DRUG

Tongxinluo,3 capsules/time 3times/day for 1 year

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tongxinluo

Tongxinluo,3 capsules/time 3times/day for 1 year

Intervention Type DRUG

placebo

3 capsules/time，3times/day for 1 year

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tongxinluo capsule placebo capsules

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- (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

Exclusion Criteria

* （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 .
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Han Yaling

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Han Yaling

vice president

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yaling Han, Dr

Role: PRINCIPAL_INVESTIGATOR

Shenyang Northern Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ShenZhou Hopital Of ShenYang Medical College

ShengYang, Liaoning, China

Site Status

The 463th Hospital Of PLA

Shenyang, Liaoning, China

Site Status

Northern Hospital

Shenyang, Liaoning, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SYNH-20120929

Identifier Type: -

Identifier Source: org_study_id