Coronary Artery DiseaseGIFTNCT00992420
Genotype Information and Functional Testing Study
An observational study of Coronary Artery Disease, run by Scripps Health at 1 site in United States.
Trial summary
This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The purpose of this study is to assess which genes influence residual platelet reactivity on standard dose clopidogrel therapy, and also to determine whether certain genes influence the incremental change in platelet reactivity with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- Type of treatment
- Pill or oral medicine
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2009to 31 Aug 2010
- 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 meeting inclusion criteria for GRAVITAS who undergo VerifyNow blood sampling for VerifyNow P2Y12 platelet function testing and IVRS entry for GRAVITAS randomization/selection determination.
Who may be able to join
- Patients meeting inclusion criteria for GRAVITAS who undergo VerifyNow blood sampling for VerifyNow P2Y12 platelet function testing and IVRS entry for GRAVITAS randomization/selection determination
Who cannot join
- See GRAVITAS trial (ClinicalTrials.gov identifier: NCT00645918)
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Genomic Medicine
La Jolla, California, 92037
About this study
Official title: GIFT: Genotype Information and Functional Testing Study
This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The purpose of this study is to assess which genes influence residual platelet reactivity on standard dose clopidogrel therapy, and also to determine whether certain genes influence the incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in patients who have high residual platelet reactivity on standard dosing.
Read the detailed description
AS DESCRIBED BY THE PI: This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The purpose of this study is to assess which genes influence residual platelet reactivity on standard dose clopidogrel therapy, and also to determine whether certain genes influence the incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in patients who have high residual platelet reactivity on standard dosing.
- Conditions
- Coronary Artery Disease
- Keywords
- thienopyridine, platelets, CYP2C19, clopidogrel, platelet function tests, platelet, genes, cytochrome P450, single nucleotide polymorphisms, Platelet Aggregation Inhibitors
- Medical subject headings
- Coronary Artery Disease
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 |
|---|---|---|
| GRAVITAS Study Arm A | "Tailored" clopidogrel regimen - total first day dose 600-mg, then 150-mg every day for 6 months | |
| GRAVITAS Study Arm B | "Standard" clopidogrel regimen - a placebo loading dose (six placebo tablets) and then clopidogrel 75-mg and 1 placebo tablet every day for 6 months. | |
| GRAVITAS Study Arm C | Responders: A random sample of clopidogrel responders treated with a placebo loading dose (six placebo tablets) and then the standard clopidogrel regimen of 75-mg and 1 placebo tablet every day for 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual platelet reactivity
Outcome 1 is residual platelet reactivity the measurement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study start1 Oct 2009
- Primary completion31 Aug 2010
- Study completion31 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Sanofi, Accumetrics, Inc.
- Responsible party
- Sponsor
- Investigators
- Matthew J Price, MD, Principal investigator, Scripps Clinic, La Jolla, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992420
- Sponsor's protocol ID
- P95082S
- Acronym
- GIFT
- Status last verified
- Nov 2022
- First submitted
- 5 Oct 2009
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Price MJ, Murray SS, Angiolillo DJ, Lillie E, Smith EN, Tisch RL, Schork NJ, Teirstein PS, Topol EJ; GIFT Investigators. Influence of genetic polymorphisms on the effect of high- and standard-dose clopidogrel after percutaneous coronary intervention: the GIFT (Genotype Information and Functional Testing) study. J Am Coll Cardiol. 2012 May 29;59(22):1928-37. doi: 10.1016/j.jacc.2011.11.068.
PubMed 22624833
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GIFT: Genotype Information and Functional Testing Study
- ClinicalTrials.gov ID
- NCT00992420
- Acronym / sponsor ID
- GIFT / P95082S
- Conditions
- Coronary Artery Disease
- Keywords
- thienopyridine, platelets, CYP2C19, clopidogrel, platelet function tests, platelet, genes, cytochrome P450
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Sanofi, Accumetrics, Inc.
- Study start
- 1 Oct 2009 (actual)
- Primary completion
- 31 Aug 2010 (actual)
- Study completion
- 31 Aug 2010 (actual)
- First posted
- 9 Oct 2009 (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.
This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The purpose of this study is to assess which genes influence residual platelet reactivity on standard dose clopidogrel therapy, and also to determine whether certain genes influence the incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in patients who have high residual platelet reactivity on standard dosing.
Detailed description
AS DESCRIBED BY THE PI: This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The purpose of this study is to assess which genes influence residual platelet reactivity on standard dose clopidogrel therapy, and also to determine whether certain genes influence the incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in patients who have high residual platelet reactivity on standard dosing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GRAVITAS Study Arm A | – | –"Tailored" clopidogrel regimen - total first day dose 600-mg, then 150-mg every day for 6 months |
| GRAVITAS Study Arm B | – | –"Standard" clopidogrel regimen - a placebo loading dose (six placebo tablets) and then clopidogrel 75-mg and 1 placebo tablet every day for 6 months. |
| GRAVITAS Study Arm C | – | –Responders: A random sample of clopidogrel responders treated with a placebo loading dose (six placebo tablets) and then the standard clopidogrel regimen of 75-mg and 1 placebo tablet every day for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients meeting inclusion criteria for GRAVITAS who undergo VerifyNow blood sampling for VerifyNow P2Y12 platelet function testing and IVRS entry for GRAVITAS randomization/selection determination.
Key inclusion criteria (1 listed)
- Patients meeting inclusion criteria for GRAVITAS who undergo VerifyNow blood sampling for VerifyNow P2Y12 platelet function testing and IVRS entry for GRAVITAS randomization/selection determination
Key exclusion criteria (1 listed)
- See GRAVITAS trial (ClinicalTrials.gov identifier: NCT00645918)
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
residual platelet reactivity
Time frame: 6 months
Outcome 1 is residual platelet reactivity the measurement
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 23 Nov 2022.
- Derived from this study: PubMed 22624833Price MJ, Murray SS, Angiolillo DJ, Lillie E, Smith EN, Tisch RL, Schork NJ, Teirstein PS, Topol EJ; GIFT Investigators. Influence of genetic polymorphisms on the effect of high- and standard-dose clopidogrel after percutaneous coronary intervention: the GIFT (Genotype Information and Functional Testing) study. J Am Coll Cardiol. 2012 May 29;59(22):1928-37. doi: 10.1016/j.jacc.2011.11.068.
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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.
Matthew J Price, MD principal investigator
Scripps Clinic, La Jolla, CA
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 Artery Disease, run by Scripps Health at 1 site in United States.
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 1 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 23 Nov 2022. 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 United States. 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?
residual platelet reactivity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00992420, which also lists 1 linked publication.
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 23 Nov 2022.