Different Platelet Activities Between Intracoronary and Peripheral Blood in Coronary Artery Disease Patients

NCT03078257 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-03-13

No results posted yet for this study

Summary

Antiplatelet treatment is important for coronary artery disease(CAD) patients .Some patients are resistant to antiplatelet treatment based on platelet function tests(PFT).Currently the results of PFT are mainly based on the analysis of peripheral blood. instead, adverse cardiovascular events in CAD patients may be more directly related to platelet activities in the coronary arteries. There's no evidence of system study to prove the PFT of peripheral blood can represent the platelet functions in coronary arteries.The purpose of this study is to determine the different platelet activities in the blood of peripheral vein (PV), peripheral artery (PA), intracoronary artery (IC) in the CAD patients without or with different interventions.

our study is divided into three parts: Part A: To study the different platelet activities in the blood of PV, PA, IC in the CAD patients with dual antiplatelet therapy.

Part B: To explore the different platelet activities of the above three sites in ST-segment elevation myocardial infarction (STEMI) patients who are administrated platelet membrane glycoprotein Ⅱb/Ⅲa (GPⅡb/Ⅲa) receptor antagonist ( tirofiban ) in PV or IC and dual antiplatelet therapy.

Part C: To explore the different platelet activities of the above three sites in STEMI patients who are administrated antiplatelet thrombolysin or placebo in PV and dual antiplatelet therapy.

Conditions

Interventions

DRUG

tirofiban in PV

a loading dose of 10ug/kg tirofiban is given in 3 min through PV,followed by a maintenance dose of 0.15ug/kg\*min for 48h. (clopidogrel 600 mg+aspirin( ASA) 300 mg)x1 day.

DRUG

tirofiban in IC

a loading dose of 10ug/kg tirofiban is given in 3 min through IC,followed by a maintenance dose of 0.15ug/kg\*min for 48h. (clopidogrel 600 mg+ ASA 300 mg)x1 day.

DRUG

antiplatelet thrombolysin

a loading dose of 5 IU/60kg in 5 min through PV,followed by a maintenance dose of 0.002 IU/kg/h for 48h. (clopidogrel 600 mg+ ASA 300 mg)x1 day.

DRUG

placebo

a loading dose of 5 IU/60kg in 5 min through PV,followed by a maintenance dose of 0.002 IU/kg/h for 48h. (clopidogrel 600 mg+ ASA 300 mg)x1 day.

DRUG

Clopidogrel

loading dose of 300 mg clopidogrel followed by a maintenance dose of 75 mg/d for at least 5 days

DRUG

Aspirin

loading dose of 300 mg aspirin followed by a maintenance dose of 100 mg/d for at least 5 days.

DRUG

Clopidogrel

loading dose of 600 mg clopidogrel followed by a maintenance dose of 75 mg/d for at least 5 days

Sponsors & Collaborators

  • National Natural Science Foundation of China

    collaborator OTHER_GOV
  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2017-11-30
Completion
2017-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03078257 on ClinicalTrials.gov