Angina, StableNCT03783351
Genotyping GUided Antiplatelet theRapy in pAtieNts Treated With Drug Eluting stEnts (GUARANTEE)
A study testing CYP2C19 genotype testing in people with Angina, Stable and Acute Coronary Syndrome, run by Beijing Anzhen Hospital at 9 sites in China.
Trial summary
The aim of this study is to assess the efficacy and safety of the CYP2C19 genotype guided antiplatelet treatment strategy, using clopidogrel in non-carriers of a CYP2C19*2 or *3 allele and ticagrelor in carriers of a CYP2C19*2 or *3 allele in patients treated with new generation drug eluting stents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina, Stable, Acute Coronary Syndrome, Drug-Eluting Stents
- What is being tested?
- CYP2C19 genotype testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,009 participants
- Where
- 9 sitesChina
- Study dates
- 27 May 2019to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient ≥18 years of age
- Patient presents with acute coronary syndrome (ACS) or stable coronary artery disease (SCAD)
- Patient has a percutaneous coronary intervention (PCI) indication and the new generation drug eluting stent(s) is successfully implanted
Who cannot join
- Patient unable to receive 12 months of dual anti-platelet therapy
- Patient developing procedure-related complications such as stent thrombosis, coronary dissection, coronary perforation, cardiac tamponade or no-reflow during PCI
- Contraindicated or allergic to clopidogrel or ticagrelor
- Patient or physician refusal to enroll in the study
- Patient having received thrombolytic therapy within the previous 24 hours
- Physician has known the patient's CYP2C19 genotype
Show all 18Show fewer
- Anticipated discontinuation of dual anti-platelet therapy within the 12-month follow-up period, example for elective surgery
- History of intracranial hemorrhage
- Patient has a history of bleeding diathesis or coagulopathy
- Patient has an active pathological bleeding, such as active gastrointestinal (GI) bleeding
- Patient is pregnant, breastfeeding, or planning to become pregnant within 12 months
- Patient is receiving chronic oral anticoagulation therapy (i.e., vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor)
- Patient with cardiogenic shock or mechanical circulatory assist devices placed
- Patient with LVEF <30%
- Patient with active liver diseases
- Patient with severe renal insufficiency (eGFR <30ml/min/1.73m2 based on simplified MDRD equation or CrCl <30ml/min based on Cockcroft-Gault equation)
- Patient has a malignancy or a life expectancy of less than one year
- Platelet count <100 000/μL, or hematocrit <32% or >52%, or white blood cell count <3000/μL
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100000
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Beijing Tong Ren Hospital
Beijing, Beijing Municipality, 100730
Beijing LuHe Hospital
Beijing, Beijing Municipality, 101199
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
China-Japan Friendship Hospital
Beijing, Beijing Municipality
About this study
Official title: CYP2C19 Genotype-GUided Dual Antiplatelet theRapy in pAtieNts Treated With New Generation Drug Eluting stEnts (the GUARANTEE Study)
The aim of this study is to assess the efficacy and safety of the CYP2C19 genotype guided antiplatelet treatment strategy, using clopidogrel in non-carriers of a CYP2C19*2 or *3 allele and ticagrelor in carriers of a CYP2C19*2 or *3 allele in patients treated with new generation drug eluting stents.
Read the detailed description
Background: P2Y12 receptor inhibitors are crucial for the management of patients undergoing coronary stenting. Although large-scale trials have shown that ticagrelor is superior to clopidogrel in terms of platelet inhibition and reduction of major adverse cardiovascular events (MACE), clopidogrel remains the most commonly used P2Y12 receptor inhibitor due to its lower price and bleeding risk. Despite the combined use of aspirin and clopidogrel, a substantial portion of patients after coronary stenting are at increased risk for adverse cardiovascular events including death, myocardial infarction, and stent thrombosis. This phenomenon may be due to the so-called clopidogrel resistance. Cytochrome P450 2C19 (CYP2C19) polymorphism plays a crucial role in the clopidogrel resistance. CYP2C19 is responsible, in part, for converting the clopidogrel prodrug into an active metabolite that irreversibly binds to the P2Y12 receptor thus inhibiting ADP-induced platelet aggregation. CYP2C19*2 and *3, which encounter loss function, have been demonstrated to be the most common genetic variants resulting in clopidogrel resistance.
Methods: Patients who undergo coronary stenting will be randomized to a prospective CYP2C19 genotype-guided antiplatelet therapy arm versus a conventional therapy arm. Venous blood collection will be completed immediately after randomization in all patients eligible for the study. The genotype results involving CYP2C19*2 and *3 allele variants will be obtained within 48 hours only in the genotyping arm. CYP2C19 *2 or *3 reduced function allele patients will receive ticagrelor 90 mg bid, whereas non-*2 or -*3 CYP2C19 patients will receive clopidogrel 75 mg once daily. The conventional therapy arm will receive either clopidogrel or ticagrelor, according to the clinical and procedural characteristics of patients. The dual antiplatelet therapy will last for at least one year in the both arms. The primary endpoints will be evaluated at one-year follow-up.
- Conditions
- Angina, Stable, Acute Coronary Syndrome, Drug-Eluting Stents, Genotype
- Being tested
- CYP2C19 genotype testing
- Medical subject headings
- Angina, Stable, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYP2C19 genotype testingGenetic
Also called clopidogrel, ticagrelor
CYP2C19 genotype testing will be conducted in a designated central laboratory.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy | No intervention | Patients randomized to the Conventional Therapy arm will receive either clopidogrel or ticagrelor, according to the clinical and procedural characteristics of patients. CYP2C19 genotyping will be performed at the end of study. |
| CYP2C19 Genotyping | Active comparator | CYP2C19 genotyping will be performed within 48 hours after randomization. CYP2C19 *2 or *3 reduced function allele patients will receive ticagrelor 90 mg bid, whereas non-*2 or -*3 CYP2C19 patients will receive clopidogrel 75 mg once daily. Receives: Genetic: CYP2C19 genotype testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)
MACCE will include all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI) and ischemia driven revascularization at one-year follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start27 May 2019
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina, StableStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,009 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yujie Zhou, Beijing Anzhen Hospital
- Investigators
- Yujie Zhou, PhD,MD, Study chair, Beijing Anzhen HospitalXiaoli Liu, PhD, MD, Study director, Beijing Anzhen HospitalXiaoteng Ma, MD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783351
- Sponsor's protocol ID
- GUARANTEE
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2018
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CYP2C19 Genotype-GUided Dual Antiplatelet theRapy in pAtieNts Treated With New Generation Drug Eluting stEnts (the GUARANTEE Study)
- ClinicalTrials.gov ID
- NCT03783351
- Acronym / sponsor ID
- GUARANTEE
- Conditions
- Angina, Stable, Acute Coronary Syndrome, Drug-Eluting Stents, Genotype
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,009 participants (actual)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 27 May 2019 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 21 Dec 2018 (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 aim of this study is to assess the efficacy and safety of the CYP2C19 genotype guided antiplatelet treatment strategy, using clopidogrel in non-carriers of a CYP2C19*2 or *3 allele and ticagrelor in carriers of a CYP2C19*2 or *3 allele in patients treated with new generation drug eluting stents.
Detailed description
Background: P2Y12 receptor inhibitors are crucial for the management of patients undergoing coronary stenting. Although large-scale trials have shown that ticagrelor is superior to clopidogrel in terms of platelet inhibition and reduction of major adverse cardiovascular events (MACE), clopidogrel remains the most commonly used P2Y12 receptor inhibitor due to its lower price and bleeding risk. Despite the combined use of aspirin and clopidogrel, a substantial portion of patients after coronary stenting are at increased risk for adverse cardiovascular events including death, myocardial infarction, and stent thrombosis. This phenomenon may be due to the so-called clopidogrel resistance. Cytochrome P450 2C19 (CYP2C19) polymorphism plays a crucial role in the clopidogrel resistance. CYP2C19 is responsible, in part, for converting the clopidogrel prodrug into an active metabolite that irreversibly binds to the P2Y12 receptor thus inhibiting ADP-induced platelet aggregation. CYP2C19*2 and *3, which encounter loss function, have been demonstrated to be the most common genetic variants resulting in clopidogrel resistance.
Methods: Patients who undergo coronary stenting will be randomized to a prospective CYP2C19 genotype-guided antiplatelet therapy arm versus a conventional therapy arm. Venous blood collection will be completed immediately after randomization in all patients eligible for the study. The genotype results involving CYP2C19*2 and *3 allele variants will be obtained within 48 hours only in the genotyping arm. CYP2C19 *2 or *3 reduced function allele patients will receive ticagrelor 90 mg bid, whereas non-*2 or -*3 CYP2C19 patients will receive clopidogrel 75 mg once daily. The conventional therapy arm will receive either clopidogrel or ticagrelor, according to the clinical and procedural characteristics of patients. The dual antiplatelet therapy will last for at least one year in the both arms. The primary endpoints will be evaluated at one-year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy | No intervention | –Patients randomized to the Conventional Therapy arm will receive either clopidogrel or ticagrelor, according to the clinical and procedural characteristics of patients. CYP2C19 genotyping will be performed at the end of study. |
| CYP2C19 Genotyping | Active comparator | Genetic: CYP2C19 genotype testingCYP2C19 genotyping will be performed within 48 hours after randomization. CYP2C19 *2 or *3 reduced function allele patients will receive ticagrelor 90 mg bid, whereas non-*2 or -*3 CYP2C19 patients will receive clopidogrel 75 mg once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient ≥18 years of age
- Patient presents with acute coronary syndrome (ACS) or stable coronary artery disease (SCAD)
- Patient has a percutaneous coronary intervention (PCI) indication and the new generation drug eluting stent(s) is successfully implanted
Key exclusion criteria (18 listed)
- Patient unable to receive 12 months of dual anti-platelet therapy
- Patient developing procedure-related complications such as stent thrombosis, coronary dissection, coronary perforation, cardiac tamponade or no-reflow during PCI
- Contraindicated or allergic to clopidogrel or ticagrelor
- Patient or physician refusal to enroll in the study
- Patient having received thrombolytic therapy within the previous 24 hours
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 |
|---|---|---|
| CYP2C19 genotype testingAlso: clopidogrel, ticagrelorCYP2C19 genotype testing will be conducted in a designated central laboratory. | Genetic | CYP2C19 Genotyping |
Primary outcome
Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: 1 year
MACCE will include all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI) and ischemia driven revascularization at one-year follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Yujie Zhou, PhD,MD study chair
Beijing Anzhen Hospital
Xiaoli Liu, PhD, MD study director
Beijing Anzhen Hospital
Xiaoteng Ma, MD principal investigator
Beijing Anzhen Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CYP2C19 genotype testing in people with Angina, Stable and Acute Coronary Syndrome, run by Beijing Anzhen Hospital at 9 sites in China.
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 3 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE) (time frame: 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 31 Dec 2025.