Thromboxane B2 and Platelet Function Testing as Measures of Aspirin Resistance in Hong Kong Chinese Patients

NCT04863053 | Completed

• 1 other identifier: ASPR
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

The hypotheses of the study are that the diagnostic accuracy of Multiplate® device for diagnosis of aspirin resistance is comparable to the serum TXB2 assay and that certain genetic polymorphisms and phenotypic factors significantly influence the antiplatelet effect of aspirin and contribute to aspirin resistance observed in this study.

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

• serum thromboxane B2 (TXB2) concentrations

  Serum TXB2 concentrations will be measured by using an enzyme immunoassay kit to assess the adequacy of platelet cyclooxygenase (COX)-1 inactivation by aspirin. Each subject will only attend on one day.

  Through study completion, an average of 1 year.

Secondary Outcomes (3)

• Multiplate® analyzer aspirin assay (ASPI test) platelet aggregation test

  Through study completion, an average of 1 year.

• Genotyping of COX1 gene, which may be related to aspirin antiplatelet effect.

  Through study completion, an average of 1 year.

• Genotyping of thromboxane A2 receptor (TBXA2R) gene, which may be related to aspirin antiplatelet effect.

  Through study completion, an average of 1 year.

Study Arms (1)

Stable CHD patient

Patients aged ≥ 18 years who have a history of stable coronary heart disease (CHD) receiving long-term mono-antiplatelet therapy with aspirin (80 mg once daily)

Other: Blood samples will be taken to assess platelet function. There is no change in treatment.

Interventions

Blood samples will be taken to assess platelet function. There is no change in treatment. OTHER

Stable CHD patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged ≥ 18 years who have a history of stable CHD receiving long-term mono-antiplatelet therapy with aspirin (80 mg once daily)

You may qualify if:

• Patients aged ≥ 18 years who have a history of stable CHD receiving long-term mono-antiplatelet therapy with aspirin (80 mg once daily) for reducing cardiovascular risk will be recruited from the outpatient clinic.

You may not qualify if:

• Patients who are currently taking ticlopidine, clopidogrel, dipyridamole or other antiplatelet / antithrombotic agents will not be recruited.
• Patients who are on regular therapy with anti-inflammatory drugs, or others drugs containing aspirin or non-steroid anti-inflammatory drugs (NSAIDS), or traditional Chinese medicine that have direct effects on the haemostatic system, such as angelica, danshen, garlic, ginger, ginkgo and motherwort will not be included unless they are willing to stop these treatments for at least 2 weeks
• Patients will not be recruited if they had MI, stroke, coronary artery bypass surgery or other revascularization procedure, unstable angina or angioplasty within 3 months of screening.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fasting blood samples will be obtained from patients immediately before and 1 hour after aspirin dose after at least 10 h fast in the study centre. Blood samples obtained in lithium heparin tube for platelet aggregation test with Multiplate® analyzer will be sent for analysis immediately after blood collection. A 10 ml blood sample obtained in EDTA tube will be used for DNA extraction.

MeSH Terms

Conditions

Coronary Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• BRIAN TOMLINSON, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 28, 2021
• Study Start: April 2, 2015
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

HK (1)