NCT01721590

Brief 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 tongxinluo.All patients will be followed up for one year.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

November 1, 2012

Last Update Submit

December 21, 2015

Conditions

Coronary Artery Disease

Keywords

high on-treatment platelet reactivityCoronary Heart DiseaseTongxinluo

Outcome Measures

Primary Outcomes (1)

  • Platelet reaction unit(PRU) measured by verifyNow

    to measure the rate of HPR(PRU ≤ 235)

    1 month

Secondary Outcomes (10)

  • Inflammation Marker (hsCRP、CD62P-CD41)

    1 month

  • Plasma fibrinogen concentration

    1 month

  • Thrombin time

    1 month

  • Prothrombin time

    1 month

  • major adverse cardiovascular events

    1 year

  • +5 more secondary outcomes

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Drug: placebo

Tongxinluo

EXPERIMENTAL

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

Drug: Tongxinluo

Interventions

TongxinluoDRUG

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

Also known as: Tongxinluo capsule
Tongxinluo
placeboDRUG

3 capsules/time，3times/day for 1 year

Also known as: placebo capsules
Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- (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

You may not qualify if:

  • （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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

ShenZhou Hopital Of ShenYang Medical College

ShengYang, Liaoning, 110032, China

Location

The 463th Hospital Of PLA

Shenyang, Liaoning, 110042, China

Location

Northern Hospital

Shenyang, Liaoning, China

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Disease

Interventions

tongxinluo

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Yaling Han, Dr

    Shenyang Northern Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
vice president

Study Record Dates

First Submitted

November 1, 2012

First Posted

November 5, 2012

Study Start

November 1, 2012

Primary Completion

May 1, 2013

Study Completion

June 1, 2014

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations

CN(3)