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
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
-
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
-
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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