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NCT Number: NCT01721590

Tongxinluo Improve High on Clopidogrel Platelet Reactivity 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ShenZhou Hopital Of ShenYang Medical College, ShengYang, Liaoning, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Tongxinluo

Drug

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

Other names: Tongxinluo capsule

Placebo

Drug

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

Other names: placebo capsules

Primary outcomes

  1. Platelet reaction unit(PRU) measured by verifyNow

    Time frame: 1 month

    to measure the rate of HPR(PRU ≤ 235)

Secondary outcomes

  1. Inflammation Marker (hsCRP、CD62P-CD41)

    Time frame: 1 month

  2. Plasma fibrinogen concentration

    Time frame: 1 month

  3. Thrombin time

    Time frame: 1 month

  4. Prothrombin time

    Time frame: 1 month

  5. major adverse cardiovascular events

    Time frame: 1 year

    Including MI,Stroke,target vessel revascularization,and all-cause mortality

  6. bleeding event

    Time frame: 1 year

  7. Adverse drug reaction and withdrawal rate

    Time frame: 1 month ,1 year

  8. Angina recurrence

    Time frame: 1 year

  9. Traditional Chinese medicine angina symptoms scores

    Time frame: 1 year

  10. Intra-stent thrombosis

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Han Yaling

Other

Registry information

Official study title

Study of Tongxinluo to Improve High on Clopidogrel Platelet Reactivity in Patients With Coronary Heart Disease

Acronym: Talent

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Nov 5, 2012
Registry last updated
Dec 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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