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

NCT03078257 | Unknown Phase 1

• 1 other identifier: 005
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Disease

Keywords

Platelet Activities; light aggregometry; VerifyNow P2Y12-assay; peripheral vein; peripheral artery; intracoronary artery; tirofiban; antiplatelet thrombolysin

Outcome Measures

Primary Outcomes (1)

• platelet aggregation

  Regional differences between blood samples from PV,PA and IC by LTA and VerifyNow P2Y12 assays.The results of LTA are reported in platelet aggregation rate（%）.Platelet aggregation was induced using 0.5 mg/ml arachidonic acid (AA) and 5 μmol/l ADP.The maximum aggregation achieved during an 8-minute period was used for analysis.The results of the VerifyNow P2Y12-assay are reported in P2Y12 reaction units (PRU).(using 20 μmol/l ADP as the agonist and 22 nmol/l prostag- landin E1 (PGE1). a value that uses iso- thrombin receptor-activating peptide to approximate a baseline off-drug platelet reactivity value, and percentage inhibition.

  2 hours

Study Arms (5)

dual antiplatelet therapy

EXPERIMENTAL

clopidogrel +aspirin

Drug: Clopidogrel; Drug: Aspirin

tirofiban in PV

EXPERIMENTAL

clopidogrel +aspirin + tirofiban in PV

Drug: tirofiban in PV; Drug: Aspirin; Drug: Clopidogrel

tirofiban in IC

EXPERIMENTAL

clopidogrel +aspirin +tirofiban in IC

Drug: tirofiban in IC; Drug: Aspirin; Drug: Clopidogrel

antiplatelet thrombolysin

EXPERIMENTAL

clopidogrel +aspirin +antiplatelet thrombolysin

Drug: antiplatelet thrombolysin; Drug: Aspirin; Drug: Clopidogrel

placebo

PLACEBO COMPARATOR

clopidogrel +aspirin +placebo

Drug: placebo; Drug: Aspirin; Drug: Clopidogrel

Interventions

tirofiban in PV DRUG

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.

Also known as: GPⅡb/Ⅲa receptor antagonist

tirofiban in PV

tirofiban in IC DRUG

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.

Also known as: GP IIb/IIIa receptor antagonist

tirofiban in IC

antiplatelet thrombolysin 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.

Also known as: GP Ib receptor antagonist

antiplatelet thrombolysin

placebo 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.

placebo

Clopidogrel DRUG

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

dual antiplatelet therapy

Aspirin DRUG

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

antiplatelet thrombolysin; dual antiplatelet therapy; placebo; tirofiban in IC; tirofiban in PV

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CAD patients plan to receive coronary arteriography (CAG) or percutaneous coronary intervention (PCI).
• Patient aged \>18 years and ≦75 years old;
• Signed inform consent

You may not qualify if:

• Allergy or intolerance to ASA, clopidogrel , tirofiban ,antiplatelet thrombolysin;
• Subjects at a high risk of bleeding (e.g. platelet count\< 100\*109/L, known bleeding diathesis , active peptic ulcer );
• Patients who are planning to take warfarin or drugs that potentially could interfere with the anti-platelet effects .
• severe hemodynamic instability
• severe liver and renal dysfunction

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Tirofiban; Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 13, 2017
• Study Start: January 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

CN (1)