Coronary Artery DiseaseGIANTNCT01134380
Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by Biotronik France at 12 sites in France.
Trial summary
The objective of GIANT Study is to evaluate the clinical impact of genetic resistance to thienopyridine profile determination (CYP2C19 gene) and the clinical impact of compliance to an adjusted thienopyridine treatment on STEMI patients treated by primary PCI within the 24 hours following the first chest pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome, Genetic Resistance to Clopidogrel
- How many people
- 1,500 participants
- Where
- 12 sitesFrance
- Study dates
- Jun 2010to Mar 2013
- 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: STEMI patients treated within the first 24 hours following the first chest pain by Primary PCI (with stent implantation)
Who may be able to join
- STEMI patient treated within the first 24 hours with primary PCI (with stent implantation)
- Age superior or equal to 18 years old
- Informed consent signed
- Patient volunteer to be submitted to the 1 year visit follow up and to the clinical exams during this visit
- Patient benefiting from French social health system
Who cannot join
- NONSTEMI patient with high troponin
- STEMI patient treated after the first 24 hours
- Stable / unstable angina or silent ischemia
- Cardiogenic shock
- Oral anticoagulation (Vitamin K Antagonists)
- Contraindication for PCI
Show all 15Show fewer
- Age inferior to 18 years old
- Life expectancy inferior to 1 year
- Participation in another clinical trial
- No signed informed consent
- Patient not available for the 1 year visit follow up
- Pregnant women
- Known allergy to media contrast that can not be controlled by an adapted treatment
- Known allergy to cobalt chromium alloy
- Left ventricular ejection fraction lower than 30%
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Centre Hospitalier de la Région Annecienne
Annecy
Hôpital Albert Schweitzer
Colmar, 68003
Centre Hospitalier Sud Francilien
Corbeil-Essonnes
Centre Hospitalier d'Haguenau
Haguenau
Centre Hospitalier Saint Joseph et Saint Luc
Lyon, 69007
Hôpital Privé Jacques Cartier
Massy, 91300
Hôpital Bon Secours
Metz
Hôpital Arnaud de Villeneuve
Montpellier
Centre Hospitalier Universitaire Caremeau
Nîmes
Groupe Hospitalier Pitié Salpêtrière
Paris
Centre Hospitalier Rene Dubos
Pontoise
CHI de Villeneuve
Villeneuve-Saint-Georges
About this study
The objective of GIANT Study is to evaluate the clinical impact of genetic resistance to thienopyridine profile determination (CYP2C19 gene) and the clinical impact of compliance to an adjusted thienopyridine treatment on STEMI patients treated by primary PCI within the 24 hours following the first chest pain.
Read the detailed description
All the STEMI patients treated by primary PCI (with stent implantation) within the 24 hours following the first chest pain can be included in the GIANT study. After the PCI, they'll receive DAT (Aspirin + Clopidogrel/Prasugrel).
Patients will then be genotyped to determine if they carry one of the CYP2C19 gene variants making them resistant or hyper responder to clopidogrel. The genetic profile of the patients will be communicated to the physician who took care of them so that he can (or not) adjust the thienopyridine treatment (increase of the clopidogrel dosage, switch to prasugrel or switch to clopidogrel). A treatment will be prescribed for 12 months as according to the European guidelines.
One year after the PCI, the patients will have to be available for a follow up visit. They'll be submitted to a VERIFY NOW P2Y12 protocol to determine whether they were compliant to their thienopyridine treatment. A clinical follow up will be also performed to evaluate the cardiovascular events.
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome, Genetic Resistance to Clopidogrel, Compliance to Thienopyridine Treatment
- Keywords
- Percutaneous coronary intervention, Acute coronary syndrome, Dual antiplatelet therapy, clopidogrel/prasugrel, genotyping, stent, compliance
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Patient Compliance
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 |
|---|---|---|
| [*1] Genotype - Good responders to Clopidogrel | This group of patients is defined thanks to the DNA extracted from their saliva: [*1] genotype patients are good responders to clopidogrel | |
| [*2] genotype with adapted thienopyridine treatment | This group of patients is defined thanks to the DNA extracted from their saliva: [*2] genotype patients are bad responders to clopidogrel and their thienopyridine treatment has been adapted |
What is being measured
The primary outcome is the main question the study is designed to answer.
statistical difference in Death, MI and stent thrombosis between genetically resistant patients (*2 genotype) with adapted treatment and non resistant patients (*1 genotype)
Measured: 12 months
Secondary outcomes (1)
Difference in MACCE between responder + compliant patients vs responders + non compliant patients vs non responder patients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2013
- Study completionMar 2013
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotronik France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center, Allies in Cardiovascular Trials Initiatives and Organized
- Investigators
- Bernard Chevalier, Principal investigator, Hopital Privé Jacques CartierGilles Montalescot, Principal investigator, Assistance Publique - Hôpitaux de ParisLoïc Belle, Principal investigator, Centre Hospitalier de la région Annecienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134380
- Sponsor's protocol ID
- GIANT200905-04
- Acronym
- GIANT
- Status last verified
- Jul 2011
- First submitted
- 28 May 2010
- Last updated
- 8 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hulot JS, Chevalier B, Belle L, Cayla G, Khalife K, Funck F, Berthier R, Piot C, Tafflet M, Montalescot G; GIANT Investigators. Routine CYP2C19 Genotyping to Adjust Thienopyridine Treatment After Primary PCI for STEMI: Results of the GIANT Study. JACC Cardiovasc Interv. 2020 Mar 9;13(5):621-630. doi: 10.1016/j.jcin.2020.01.219.
PubMed 32139220
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment
- ClinicalTrials.gov ID
- NCT01134380
- Acronym / sponsor ID
- GIANT / GIANT200905-04
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome, Genetic Resistance to Clopidogrel, Compliance to Thienopyridine Treatment
- Keywords
- Percutaneous coronary intervention, Acute coronary syndrome, Dual antiplatelet therapy, clopidogrel/prasugrel, genotyping, stent, compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Biotronik FranceIndustry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center, Allies in Cardiovascular Trials Initiatives and Organized
- Study start
- Jun 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Jun 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.
The objective of GIANT Study is to evaluate the clinical impact of genetic resistance to thienopyridine profile determination (CYP2C19 gene) and the clinical impact of compliance to an adjusted thienopyridine treatment on STEMI patients treated by primary PCI within the 24 hours following the first chest pain.
Detailed description
All the STEMI patients treated by primary PCI (with stent implantation) within the 24 hours following the first chest pain can be included in the GIANT study. After the PCI, they'll receive DAT (Aspirin + Clopidogrel/Prasugrel).
Patients will then be genotyped to determine if they carry one of the CYP2C19 gene variants making them resistant or hyper responder to clopidogrel. The genetic profile of the patients will be communicated to the physician who took care of them so that he can (or not) adjust the thienopyridine treatment (increase of the clopidogrel dosage, switch to prasugrel or switch to clopidogrel). A treatment will be prescribed for 12 months as according to the European guidelines.
One year after the PCI, the patients will have to be available for a follow up visit. They'll be submitted to a VERIFY NOW P2Y12 protocol to determine whether they were compliant to their thienopyridine treatment. A clinical follow up will be also performed to evaluate the cardiovascular events.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [*1] Genotype - Good responders to Clopidogrel | – | –This group of patients is defined thanks to the DNA extracted from their saliva: [*1] genotype patients are good responders to clopidogrel |
| [*2] genotype with adapted thienopyridine treatment | – | –This group of patients is defined thanks to the DNA extracted from their saliva: [*2] genotype patients are bad responders to clopidogrel and their thienopyridine treatment has been adapted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STEMI patients treated within the first 24 hours following the first chest pain by Primary PCI (with stent implantation)
Key inclusion criteria (5 listed)
- STEMI patient treated within the first 24 hours with primary PCI (with stent implantation)
- Age superior or equal to 18 years old
- Informed consent signed
- Patient volunteer to be submitted to the 1 year visit follow up and to the clinical exams during this visit
- Patient benefiting from French social health system
Key exclusion criteria (15 listed)
- NONSTEMI patient with high troponin
- STEMI patient treated after the first 24 hours
- Stable / unstable angina or silent ischemia
- Cardiogenic shock
- Oral anticoagulation (Vitamin K Antagonists)
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
statistical difference in Death, MI and stent thrombosis between genetically resistant patients (*2 genotype) with adapted treatment and non resistant patients (*1 genotype)
Time frame: 12 months
1 secondary outcome
Difference in MACCE between responder + compliant patients vs responders + non compliant patients vs non responder patients.
Time frame: 12 months
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 8 Oct 2014.
- Derived from this study: PubMed 32139220Hulot JS, Chevalier B, Belle L, Cayla G, Khalife K, Funck F, Berthier R, Piot C, Tafflet M, Montalescot G; GIANT Investigators. Routine CYP2C19 Genotyping to Adjust Thienopyridine Treatment After Primary PCI for STEMI: Results of the GIANT Study. JACC Cardiovasc Interv. 2020 Mar 9;13(5):621-630. doi: 10.1016/j.jcin.2020.01.219.
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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.
Bernard Chevalier principal investigator
Hopital Privé Jacques Cartier
Gilles Montalescot principal investigator
Assistance Publique - Hôpitaux de Paris
Loïc Belle principal investigator
Centre Hospitalier de la région Annecienne
12 sites 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 and Acute Coronary Syndrome, run by Biotronik France at 12 sites in France.
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 5 inclusion and 15 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 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. 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?
statistical difference in Death, MI and stent thrombosis between genetically resistant patients (*2 genotype) with adapted treatment and non resistant patients (*1 genotype) (time frame: 12 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 NCT01134380, 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 8 Oct 2014.