Trial | NCT01721590  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tongxinluo ...

  • Study Participants

    134
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.
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 Started
Nov 30
2012
Primary Completion
May 31
2013
Study Completion
Jun 30
2014
Last Update
Dec 23
2015
Estimate

Drug Tongxinluo

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

  • Other names: Tongxinluo capsule

Drug placebo

3 capsules/time，3times/day for 1 year

  • Other names: placebo capsules

Control Placebo Comparator

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

Tongxinluo Experimental

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

Criteria 

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 .
No Results Posted