Downstream Molecular Signals of P2Y12 Receptors in Hyporeactive Patients Under Clopidogrel Treatment A Possible Mechanism of HOTPR(High On-Treatment Platelet Reactivity)

NCT03190005 | Completed Results DMC

• 1 other identifier: TCHIRB-10603117-E
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators designed the following experiment to observe the pattern of administration in vitro, which can be completely excluded liver enzyme cytochrome P450 metabolism under the influence and observe the relevant P2Y12 receptor downstream signal changes, hope in the above experiments, that the human body directly for the difference between the existence of drug reactions exist.

Conditions

Stable Angina

Keywords

PRU; P2Y12 receptor

Outcome Measures

Primary Outcomes (1)

• PRU(Platelet Rreactivity Unit) 24 Hours After DAPT(Dual AntiPlatelet Therapy) Western Blot After Medication

  PRU(Platelet Rreactivity Unit) 24 hours after DAPT(Dual AntiPlatelet Therapy) Western blot after medication

  24 hours

Study Arms (7)

group 1

placebo control without medication.

Drug: Placebos

group 2

hyper-reactive responser after clopidogrel.

Drug: clopidogrel

group 3

hypo-reactive responser after clopidogrel.

Drug: clopidogrel

group 4

normo-reactive responser after clopidogrel.

Drug: clopidogrel

group 5

reaction after OPC-13013

Drug: clopidogrel

group 6

reaction after AR-C

Drug: clopidogrel

group 7

reaction after simastatin

Drug: clopidogrel

Interventions

clopidogrel DRUG

routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)

group 2; group 3; group 4; group 5; group 6; group 7

Placebos DRUG

no medication, healthy subjects.

group 1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

stable angina who received routine dual antiplatelet agents therapy.

You may qualify if:

• DAPT(Dual antiplatelet therapy) after regular stent implantation.

You may not qualify if:

• allergy to DAPT(Dual antiplatelet therapy). major bleeding intolerance to DAPT(Dual antiplatelet therapy).

Sponsors & Collaborators

• Taipei City Hospital: lead

Study Sites (1)

Taipei city hospital

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

downstream molecular signals of P2Y12 receptor in the platelet(Platelet Rich Plasma).

MeSH Terms

Conditions

Angina, Stable

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: chen yueh-chung
• Organization: taipei city hospital

chenyuehchung.tw@yahoo.com.tw

88627093600

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 16, 2017
• Study Start: January 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 21, 2019
• Results First Posted: November 21, 2019

Record last verified: 2017-06

Locations

TW (1)