Coronary Artery DiseasePhase 4NCT01823185
Bedside Testing of CYP2C19 Gene for Treatment of Patients With PCI With Antiplatelet Therapy
A Phase 4 study testing clopidogrel and Ticagrelor or prasugrel in people with Coronary Artery Disease and Myocardial Infarction, run by Imam Abdulrahman Bin Faisal University at 4 sites in Saudi Arabia.
Trial summary
Clopidogrel is crucial as antiplatelet treatment in patients undergoing percutaneous coronary intervention (PCI) with stent implantation and during one year after PCI, to prevent atherothrombotic complications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction, Heart Disease
- What is being tested?
- clopidogrel and Ticagrelor or prasugrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 4 sitesSaudi Arabia
- Study dates
- Mar 2013to Mar 2016
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient presents with acute myocardial infarction of more than 30 minutes and less than 12 hours
- Patient eligible for PCI
Who cannot join
- Life expectancy of less than one year
- Previously Known genotype
- Receiving chemotherapy for malignancy
- On dialysis or receiving immunosuppressive therapy or have autoimmune disease
- Hepatic impairment
- History of bleeding diathesis
Show all 14Show fewer
- Receiving vitamin K antagonist therapy
- Confirmed hypertension
- Out of normal range platelet count
- History of major surgery
- Severe trauma or fracture
- Pregnancy and lactation
- Concomitant use of simvastatin, cytochrome P450 3A4 inhibitors or inducers
- Hypersensitivity to clopidogrel or ticagrelor or prasugrel
Trial locations and contacts
4 sites in 1 country.
Saudi Arabia4 sites, 4 recruiting
- Recruiting
Prince Sultan Cardiac center
Al-Hasa, 31982
Abdullah Alabdulgader, MD
- Recruiting
Saud Al-Babtain Cardiac Center
Dammam, 31463
Hamid Al-Omran, MD
Mustafa Al-Refaei, MD
- Recruiting
King Fahd Military Medical Complex
Dammam, 31932
Khalid Al-Fraiedi, MD
- Recruiting
King Fahd University Hospital
Khobar, 31441
Abdullah M Al-Rubaish, MD
Fahd A Al-Muhanna, MD
About this study
Official title: Bedside Testing of the CYP2C19 Gene to Asses Effectiveness of Clopidogrel in Coronary Artery Disease Patients Treated With Percutaneous Coronary Intervention : Individualized Antiplatelet Drugs Treatment to Improve Prognosis
Clopidogrel is crucial as antiplatelet treatment in patients undergoing percutaneous coronary intervention (PCI) with stent implantation and during one year after PCI, to prevent atherothrombotic complications. However, clopidogrel is ineffective in certain patients due to genetic mutation in CYP2C19 gene a specific enzyme in the liver required for metabolism of clopidogrel. Therefore, the purpose of this study is to test these patients genetically at bedside and prescribe an alternative drug such as Ticagrelor (90 mg twice daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight < 60kg) if they are carriers of the allele 2 or 3 of the mutated gene.
Read the detailed description
Clopidogrel is crucial as antiplatelet treatment in patients undergoing percutaneous coronary intervention (PCI) with stent implantation and during one year after PCI, to prevent atherothrombotic complications. Clopidogrel is converted into its active metabolite by Cytochrome P2C19 (CYP2C19). However 30 % of the Saudi population is carrier of the non functional CYP2C19*2 or *3 alleles having an impaired CYP2C19 capacity, resulting in decreased effectiveness of Clopidogrel. These patients have a 42% higher risk for major cardiovascular events (MACE) compared to non carriers. Further 50 % of the MACE occurs in the first 48 hours. Therefore Ticagrelor (90 mg twice daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight < 60kg) whose actions are not dependent on conversion by CYP2C19 may be an alternative only in carriers of the non functional CYP2C19*2 or *3 alleles. This might be cost effective and prevent patients form MACE. Therefore the objective of this study is to assess the efficacy, complication free survival, safety and cost-effectiveness of the CYP2C19 genotype guided antiplatelet treatment strategy, using clopidogrel or prasugrel (or Ticlid). All participants will be followed for one year using follow up questionnaires.
- Conditions
- Coronary Artery Disease, Myocardial Infarction, Heart Disease, Vascular Disease, Angina Pectoris, Cardiovascular Disease
- Being tested
- clopidogrel, Ticagrelor or prasugrel
- Keywords
- Clopidogrel, Ticagrelor, Prasugrel, Platelet aggregation inhibitor, Dammam University, King Fahd Hospital, Purinergic P2 receptor Antagonists
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Heart Diseases, Vascular Diseases, Angina Pectoris, Cardiovascular Diseases, Ischemia, Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelDrug
Also called Clavix
Genotyping will be carried out using Spartan genotyping System on all intervention group and those patients who do not carry the CYP2C19 allele 2 or 3 will be given clopidogrel (75 mg per day) while all patients who carry the CYP2C19 allele 2 or 3 will be prescribed Ticagrelor (90 mg twice daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight < 60kg) according to local protocol.
Ticagrelor or prasugrelDrug
Also called Brilinta, Prasuvas
ticagrelor (90 mg twice daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight < 60kg) according to local protocol.
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Active comparator | CYP2C19 genotyping will be carried out at the end of the study period. Clopidogrel will be used for treatment for one year according to local protocol. Patients will receive clopidogrel 75 mg per day. Receives: Drug: clopidogrel |
| Ticagrelor or prasugrel | Experimental | Ticagrelor (90 mg twice daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight < 60kg) according to local protocol. Receives: Drug: Ticagrelor or prasugrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular event
The primary end point is the number of patients who develop adverse major cardiovascular event which include recurrent myocardial infarction, non-fatal stroke, cardiovascular mortality, severe ischemia, major bleeding at 30days after PCI.
Measured: 1 year
Secondary outcomes (1)
Mortality
Secondary efficacy endpoints are the number of patients who either died , died from cardiovascular death, from cerebrovascular death, developed recurrent MI, stent thrombosis, underwent urgent target vessel revascularization, developed stroke or combination of above
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2016 (estimated)
- Study completionMar 2016 (estimated)
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Collaborators
- King Fahad Armed Forces Hospital, Dammam Central Hospital
- Responsible party
- Sponsor
- Investigators
- Abdullah M Al-Rubaish, MD, Principal investigator, Imam Abdulrahman Bin Faisal UniversityAmein K Al-Ali, PhD, Study director, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823185
- Sponsor's protocol ID
- STGUD005
- Status last verified
- Jan 2016
- First submitted
- 19 Mar 2013
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Al-Rubaish AM, Al-Muhanna FA, Alshehri AM, Al-Mansori MA, Alali RA, Khalil RM, Al Faraidy KA, Cyrus C, Sulieman MM, Vatte C, Claassens DMF, Ten Berg JM, Asselbergs FW, Al-Ali AK. Bedside testing of CYP2C19 gene for treatment of patients with PCI with antiplatelet therapy. BMC Cardiovasc Disord. 2020 Jun 3;20(1):268. doi: 10.1186/s12872-020-01558-2.
PubMed 32493215
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Testing of the CYP2C19 Gene to Asses Effectiveness of Clopidogrel in Coronary Artery Disease Patients Treated With Percutaneous Coronary Intervention : Individualized Antiplatelet Drugs Treatment to Improve Prognosis
- ClinicalTrials.gov ID
- NCT01823185
- Acronym / sponsor ID
- STGUD005
- Conditions
- Coronary Artery Disease, Myocardial Infarction, Heart Disease, Vascular Disease, Angina Pectoris, Cardiovascular Disease
- Keywords
- Clopidogrel, Ticagrelor, Prasugrel, Platelet aggregation inhibitor, Dammam University, King Fahd Hospital, Purinergic P2 receptor Antagonists
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Collaborators
- King Fahad Armed Forces Hospital, Dammam Central Hospital
- Study start
- Mar 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 4 Apr 2013 (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.
Clopidogrel is crucial as antiplatelet treatment in patients undergoing percutaneous coronary intervention (PCI) with stent implantation and during one year after PCI, to prevent atherothrombotic complications. However, clopidogrel is ineffective in certain patients due to genetic mutation in CYP2C19 gene a specific enzyme in the liver required for metabolism of clopidogrel. Therefore, the purpose of this study is to test these patients genetically at bedside and prescribe an alternative drug such as Ticagrelor (90 mg twice daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight < 60kg) if they are carriers of the allele 2 or 3 of the mutated gene.
Detailed description
Clopidogrel is crucial as antiplatelet treatment in patients undergoing percutaneous coronary intervention (PCI) with stent implantation and during one year after PCI, to prevent atherothrombotic complications. Clopidogrel is converted into its active metabolite by Cytochrome P2C19 (CYP2C19). However 30 % of the Saudi population is carrier of the non functional CYP2C19*2 or *3 alleles having an impaired CYP2C19 capacity, resulting in decreased effectiveness of Clopidogrel. These patients have a 42% higher risk for major cardiovascular events (MACE) compared to non carriers. Further 50 % of the MACE occurs in the first 48 hours. Therefore Ticagrelor (90 mg twice daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight < 60kg) whose actions are not dependent on conversion by CYP2C19 may be an alternative only in carriers of the non functional CYP2C19*2 or *3 alleles. This might be cost effective and prevent patients form MACE. Therefore the objective of this study is to assess the efficacy, complication free survival, safety and cost-effectiveness of the CYP2C19 genotype guided antiplatelet treatment strategy, using clopidogrel or prasugrel (or Ticlid). All participants will be followed for one year using follow up questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Active comparator | Drug: clopidogrelCYP2C19 genotyping will be carried out at the end of the study period. Clopidogrel will be used for treatment for one year according to local protocol. Patients will receive clopidogrel 75 mg per day. |
| Ticagrelor or prasugrel | Experimental | Drug: Ticagrelor or prasugrelTicagrelor (90 mg twice daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight < 60kg) according to local protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient presents with acute myocardial infarction of more than 30 minutes and less than 12 hours
- Patient eligible for PCI
Key exclusion criteria (14 listed)
- Life expectancy of less than one year
- Previously Known genotype
- Receiving chemotherapy for malignancy
- On dialysis or receiving immunosuppressive therapy or have autoimmune disease
- Hepatic impairment
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 |
|---|---|---|
| clopidogrelAlso: ClavixGenotyping will be carried out using Spartan genotyping System on all intervention group and those patients who do not carry the CYP2C19 allele 2 or 3 will be given clopidogrel (75 mg per day) while all patients who carry the CYP2C19 allele 2 or 3 will be prescribed Ticagrelor (90 mg twice daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight < 60kg) according to local protocol. | Drug | Clopidogrel |
| Ticagrelor or prasugrelAlso: Brilinta, Prasuvasticagrelor (90 mg twice daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight < 60kg) according to local protocol. | Drug | Ticagrelor or prasugrel |
Primary outcome
cardiovascular event
Time frame: 1 year
The primary end point is the number of patients who develop adverse major cardiovascular event which include recurrent myocardial infarction, non-fatal stroke, cardiovascular mortality, severe ischemia, major bleeding at 30days after PCI.
1 secondary outcome
Mortality
Time frame: 30 days and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
- Derived from this study: PubMed 32493215Al-Rubaish AM, Al-Muhanna FA, Alshehri AM, Al-Mansori MA, Alali RA, Khalil RM, Al Faraidy KA, Cyrus C, Sulieman MM, Vatte C, Claassens DMF, Ten Berg JM, Asselbergs FW, Al-Ali AK. Bedside testing of CYP2C19 gene for treatment of patients with PCI with antiplatelet therapy. BMC Cardiovasc Disord. 2020 Jun 3;20(1):268. doi: 10.1186/s12872-020-01558-2.
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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.
Abdullah M Al-Rubaish, MD principal investigator
Imam Abdulrahman Bin Faisal University
Amein K Al-Ali, PhD study director
Imam Abdulrahman Bin Faisal University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clopidogrel and Ticagrelor or prasugrel in people with Coronary Artery Disease and Myocardial Infarction, run by Imam Abdulrahman Bin Faisal University at 4 sites in Saudi Arabia.
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 2 inclusion and 14 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 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Saudi Arabia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Amein K Al-Ali, PhD (+966505821693, ameinomran@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular event (time frame: 1 year). 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 NCT01823185, 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 22 Jan 2016.