Coronary DiseaseNCT04863053
Thromboxane B2 and Platelet Function Testing as Measures of Aspirin Resistance in Hong Kong Chinese Patients
An observational study of Coronary Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Blood samples will be taken to assess platelet function. There is no change in treatment.
- How many people
- 266 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Apr 2015to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Serum Thromboxane B2 and Platelet Function Testing With the Multiplate® Device as Measures of Aspirin Resistance in Hong Kong Chinese Patients With Increased Cardiovascular Risk With Stable Coronary Heart Disease
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.
Read the detailed description
Fasting blood samples will be obtained from patients in the study centre after fasting overnight for at least 10 hours immediately before and 1 hour after the 80 mg aspirin dose. A 5-ml blood sample will be obtained in a serum separator tube and allowed to clot at room temperature followed by centrifugation at 4 degrees C. Separated serum will be stored in aliquots at -80°C until analysis of TXB2. A 3-ml blood sample will be obtained in a hirudin blood tube for the platelet aggregation test with the Multiplate® analyzer which will be performed within 3 hours after blood collection. A 10 ml blood sample will be obtained in an ethylene diamine tetra acetic acid (EDTA) tube to be used for DNA extraction. During the study, a total of 26 ml blood will be taken from each participant. Morning urine samples before and 1 hour after aspirin ingestion will also be collected and stored at -80 °C until measurement.
The platelet activity of the samples will be measured with the hirudin blood using the Multiplate analyzer from Roche (Roche Diagnostics International Ltd, CH-6343 Rotkreuz, Switzerland) according to the manufacturer's instructions for the arachidonic acid induced platelet aggregation (ASPI) test. It will be analyzed within 0.5-3 hours after blood collection.
The serum samples will be assayed for TXB2 with EIA kits from Cayman (Item no. 501020, Cayman Chemical, MI, USA) according to the manufacturer's instructions.
The urine will be assayed for 11-dehydro TXB2 using the enzyme-linked immunosorbent assay (EIA) kit from Cayman (Item no. 519510, Cayman Chemical, MI, USA) according to the manufacturer's instructions. The data will then be standardized with urinary creatinine measured with Cayman creatinine (urinary) colorimetric assay kit (item no 500701).
The 11-dehydro TXB2 data will be standardized with the urinary creatinine levels measured by Creatinine (urinary) Colorimetric Assay kit from Cayman (Item no. 500701, Cayman Chemical, MI, USA) according to the manufacturer's instructions.
Genomic DNA of the patients will be extracted from EDTA blood by using phenol chloroform. The following six single nucleotide polymorphisms (SNPs) will be investigated initially: ITGA2 rs1126643, ITGA2B rs5911, PTGS1 rs1330344, ADK rs16931294, PEAR1 rs12041331 and COX2 rs20417. The SNPs will be assayed with TaqMan SNP genotyping assays from Applied Biosystems (Applied Biosystems, Foster City, CA, USA) by Thermo Fisher Scientific according to the product inserts.
- Conditions
- Coronary Disease
- Being tested
- Blood samples will be taken to assess platelet function. There is no change in treatment.
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples will be taken to assess platelet function. There is no change in treatment.Other
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Blood samples will be taken to assess platelet function. There is no change in treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (3)
Multiplate® analyzer aspirin assay (ASPI test) platelet aggregation test
Multiplate® analyzer aspirin assay (ASPI test) platelet aggregation test will be measured by impedance aggregometry using the Multiplate® analyzer. Whole blood aggregation is performed using the on screen Multiplate protocol. Each subject will only attend on one day.
Measured: Through study completion, an average of 1 year.
Genotyping of COX1 gene, which may be related to aspirin antiplatelet effect.
The COX1 gene polymorphism will be determined to assess if it is related to the aspirin antiplatelet effect measured by the ASPI test.
Measured: Through study completion, an average of 1 year.
Genotyping of thromboxane A2 receptor (TBXA2R) gene, which may be related to aspirin antiplatelet effect.
The TBXA2R gene polymorphisms will be determined to assess if it is related to the aspirin antiplatelet effect measured by the ASPI test.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start2 Apr 2015
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Tomlinson, Chinese University of Hong Kong
- Investigators
- BRIAN TOMLINSON, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863053
- Sponsor's protocol ID
- ASPR
- Status last verified
- Apr 2021
- First submitted
- 16 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Serum Thromboxane B2 and Platelet Function Testing With the Multiplate® Device as Measures of Aspirin Resistance in Hong Kong Chinese Patients With Increased Cardiovascular Risk With Stable Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT04863053
- Acronym / sponsor ID
- ASPR
- Conditions
- Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 2 Apr 2015 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fasting blood samples will be obtained from patients in the study centre after fasting overnight for at least 10 hours immediately before and 1 hour after the 80 mg aspirin dose. A 5-ml blood sample will be obtained in a serum separator tube and allowed to clot at room temperature followed by centrifugation at 4 degrees C. Separated serum will be stored in aliquots at -80°C until analysis of TXB2. A 3-ml blood sample will be obtained in a hirudin blood tube for the platelet aggregation test with the Multiplate® analyzer which will be performed within 3 hours after blood collection. A 10 ml blood sample will be obtained in an ethylene diamine tetra acetic acid (EDTA) tube to be used for DNA extraction. During the study, a total of 26 ml blood will be taken from each participant. Morning urine samples before and 1 hour after aspirin ingestion will also be collected and stored at -80 °C until measurement.
The platelet activity of the samples will be measured with the hirudin blood using the Multiplate analyzer from Roche (Roche Diagnostics International Ltd, CH-6343 Rotkreuz, Switzerland) according to the manufacturer's instructions for the arachidonic acid induced platelet aggregation (ASPI) test. It will be analyzed within 0.5-3 hours after blood collection.
The serum samples will be assayed for TXB2 with EIA kits from Cayman (Item no. 501020, Cayman Chemical, MI, USA) according to the manufacturer's instructions.
The urine will be assayed for 11-dehydro TXB2 using the enzyme-linked immunosorbent assay (EIA) kit from Cayman (Item no. 519510, Cayman Chemical, MI, USA) according to the manufacturer's instructions. The data will then be standardized with urinary creatinine measured with Cayman creatinine (urinary) colorimetric assay kit (item no 500701).
The 11-dehydro TXB2 data will be standardized with the urinary creatinine levels measured by Creatinine (urinary) Colorimetric Assay kit from Cayman (Item no. 500701, Cayman Chemical, MI, USA) according to the manufacturer's instructions.
Genomic DNA of the patients will be extracted from EDTA blood by using phenol chloroform. The following six single nucleotide polymorphisms (SNPs) will be investigated initially: ITGA2 rs1126643, ITGA2B rs5911, PTGS1 rs1330344, ADK rs16931294, PEAR1 rs12041331 and COX2 rs20417. The SNPs will be assayed with TaqMan SNP genotyping assays from Applied Biosystems (Applied Biosystems, Foster City, CA, USA) by Thermo Fisher Scientific according to the product inserts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stable CHD patient | – | Other: Blood samples will be taken to assess platelet function. There is no change in treatment.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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples will be taken to assess platelet function. There is no change in treatment. | Other | Stable CHD patient |
Primary outcome
serum thromboxane B2 (TXB2) concentrations
Time frame: Through study completion, an average of 1 year.
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.
3 secondary outcomes
Multiplate® analyzer aspirin assay (ASPI test) platelet aggregation test
Time frame: Through study completion, an average of 1 year.
Genotyping of COX1 gene, which may be related to aspirin antiplatelet effect.
Time frame: Through study completion, an average of 1 year.
Genotyping of thromboxane A2 receptor (TBXA2R) gene, which may be related to aspirin antiplatelet effect.
Time frame: Through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BRIAN TOMLINSON, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum thromboxane B2 (TXB2) concentrations (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021; AzTrials last refreshed its copy on 31 Oct 2026.