Acute Coronary SyndromeNCT01255267
The Correlation Between Genetic Polymorphism, Platelet Activity, Clopidogrel Responsiveness, and Serum Adipokine Concentration in Asian Acute Coronary Syndrome Patients
An observational study of Acute Coronary Syndrome and Chronic Coronary Artery Disease, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
In this study, we evaluate the acute coronary syndrome patients to see if there is correlation between platelet activity, genetic polymorphism (CYP2C19 and ABCB1), serum adipokines level, and Clopidogrel responsiveness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome, Chronic Coronary Artery Disease
- How many people
- Not given
- Where
- 1 siteTaiwan
- Study dates
- Start not givento not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Acute coronary syndrome and chronic coronary artery diseae patients
Who may be able to join
- Age > 18 y/o
- Acute coronary syndrome patients
- Chronic coronary artery disease patients
- Healthy volunteers
Who cannot join
- Patient refusal
- Allergy to Clopidogrel
- Receive Gp IIb/IIIa inhibitor simultaneously
- Cancer history
- Severe renal and liver function impairment
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung
Yu-Chen Wang, MD, 886-4-22052121 ext. 2371, richard9250@yahoo.com.tw
About this study
Official title: The Correlation Between Genetic Polymorphism, Platelet Activity, , Clopidogrel Responsiveness, and Serum Adipokine Concentration in Asian Acute Coronary Syndrome Patients
In this study, we evaluate the acute coronary syndrome patients to see if there is correlation between platelet activity, genetic polymorphism (CYP2C19 and ABCB1), serum adipokines level, and Clopidogrel responsiveness.
- Keywords
- Acute coronary syndrome and chronic coronary artery disease patients
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute coronary syndrome patients | Not described | |
| Chronic coronary artery disease patients | Not described | |
| Healthy control | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255267
- Sponsor's protocol ID
- DMR99-IRB-041
- Status last verified
- Dec 2010
- First submitted
- 6 Dec 2010
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Genetic Polymorphism, Platelet Activity, , Clopidogrel Responsiveness, and Serum Adipokine Concentration in Asian Acute Coronary Syndrome Patients
- ClinicalTrials.gov ID
- NCT01255267
- Acronym / sponsor ID
- DMR99-IRB-041
- Keywords
- Acute coronary syndrome and chronic coronary artery disease patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- First posted
- 7 Dec 2010 (estimated)
- 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.
In this study, we evaluate the acute coronary syndrome patients to see if there is correlation between platelet activity, genetic polymorphism (CYP2C19 and ABCB1), serum adipokines level, and Clopidogrel responsiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute coronary syndrome patients | – | – |
| Chronic coronary artery disease patients | – | – |
| Healthy control | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Acute coronary syndrome and chronic coronary artery diseae patients
Key inclusion criteria (4 listed)
- Age > 18 y/o
- Acute coronary syndrome patients
- Chronic coronary artery disease patients
- Healthy volunteers
Key exclusion criteria (6 listed)
- Patient refusal
- Allergy to Clopidogrel
- Receive Gp IIb/IIIa inhibitor simultaneously
- Cancer history
- Severe renal and liver function impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2010.
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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.
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 Acute Coronary Syndrome and Chronic Coronary Artery Disease, run by China Medical University Hospital at 1 site in Taiwan.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Dec 2010. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chen Wang, MD (886-4-22052121 ext. 2371, richard9250@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 7 Dec 2010.