Myocardial InfarctionPhase 4NCT03161678

CES1 Crossover Trial of Clopidogrel and Ticagrelor

A Phase 4 study testing Clopidogrel and Ticagrelor in people with Myocardial Infarction and Thrombosis, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Myocardial Infarction, Thrombosis, Platelet Dysfunction
What is being tested?: Clopidogrel and Ticagrelor
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 111 participants
Where: 1 siteUnited States
Study dates: 22 Aug 2017to 12 Dec 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Of Amish descent
Age 18 to 75 years
Participant in the Phamacogenomics of Anti-Platelet Intervention (PAPI-1) Study or other Amish Research Center study, or a family member of an Amish Research Center study participant.

Who cannot join

Clopidogrel or ticagrelor allergy
Platelet count < 100,000 mm3 or > 500,000 mm3
Hematocrit (Hct) < 32% or > 50%
Blood pressure > 160/95 mm Hg
Co-existing malignancy
Creatinine > 2.0 mg/dl

Show all 18Show fewer

Aspartate transaminase (AST) or alanine transaminase (ALT) > 2 times the upper limit of normal
Thyroid-stimulating hormone (TSH) < 0.40 or > 5.50 mU/L
Pregnant or breast feeding
History of gastrointestinal bleeding, a major life-threatening bleeding event, active pathological bleeding, bleeding diathesis, or coagulopathy
History of stroke or transient ischemic attack, deep vein thrombosis, or atrial fibrillation
History of myocardial infarction, coronary artery bypass surgery, unstable angina, or angioplasty
History of sick sinus syndrome, 2nd or 3rd degree atrioventricular block, or bradycardia-related syncope
Type 1 or Type 2 diabetes mellitus
Surgery in the past 3 months or planned surgery in the next 3 months
Participant cannot willingly and safely discontinue medications that, in the opinion of the study physician would affect the outcomes to be measured for at least 1 week prior to study initiation through completion of the study
Participant is unwilling to discontinue taking vitamins and/or supplements that, in the opinion of the study physician would affect the outcomes to be measured for 1 week prior to the study initiation through the the completion of the study
Any other condition that would place prospective participants at unacceptable risk or render them unable to meet the requirements of the protocol in the opinion of the site investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

Amish Research Clinic
Lancaster, Pennsylvania, 17602

Other trials in United States

About this study

Official title: Impact of Genetic Variation in CES1 on Antiplatelet Therapy

The purpose of this investigation is to evaluate when genetic variation in the carboxylesterase 1 (CES1) gene influences antiplatelet therapy response, as assessed by ex vivo platelet aggregometry, in healthy participants treated with clopidogrel and ticagrelor. We hypothesize that genetic variation in CES1 will significantly impact on-clopidogrel platelet aggregation while having a minimal effect in ticagrelor-treated subjects.

Specific Aim: To conduct a prospective randomized crossover study of clopidogrel and ticagrelor in healthy individuals stratified by CES1 genotype. Participants will be recruited by CES1 genotype into a randomized crossover study of clopidogrel (75 mg daily for 7d) and ticagrelor (90 mg twice daily for 7d) with extensive phenotyping including ex vivo platelet aggregometry performed pre- and post-drug administration in order to assess the interaction of genotype and drug choice on on-treatment platelet function.

Conditions: Myocardial Infarction, Thrombosis, Platelet Dysfunction
Being tested: Clopidogrel, Ticagrelor
Keywords: Pharmacogenetics, Carboxylesterase 1 (CES1), Antiplatelet therapy
Medical subject headings: Myocardial Infarction, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClopidogrelDrug
Also called Plavix
Clopidogrel (75 mg/d for 8 days) will be administered. Measures of pharmacodynamics will be assessed pre- and post-drug administration.
TicagrelorDrug
Also called Brilinta
Ticagrelor (90 mg twice daily for 8 days) will be administered. Measures of pharmacodynamics will be assessed pre- and post-drug administration.

Study groups in NCT03161678
Study group	Role	What they receive
Wild-Type Genotype	Active comparator	Research subjects with wild type CES1 genotypes will be studied before and after oral ingestion of clopidogrel (75 mg/d for 8 days) and ticagrelor (90 mg twice daily for 8 days) treatment. Receives: Drug: Clopidogrel; Drug: Ticagrelor
Carriers of the CES1 G143E Mutation	Experimental	Research subjects who carry the CES1 G143E allele (rs71647871) will be studied before and after oral ingestion of clopidogrel (75 mg/d for 8 days) and ticagrelor (90 mg twice daily for 8 days) treatment. Receives: Drug: Clopidogrel; Drug: Ticagrelor
Carriers of CES1 rs7498748 Mutation	Experimental	Research subjects who carry a CES1 rs7498748 minor allele will be studied before and after oral ingestion of clopidogrel (75 mg/d for 8 days) and ticagrelor (90 mg twice daily for 8 days) treatment. Receives: Drug: Clopidogrel; Drug: Ticagrelor

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Maximal Platelet Aggregation in Response to Clopidogrel
Ex vivo platelet aggregometry was performed in platelet rich plasma (PRP) after stimulation with 20 μM adenosine diphosphate (ADP) at 2 time points (at baseline prior to drug administration and on the 8th day of clopidogrel [75mg/d]). Maximum platelet aggregation is recorded by the platelet aggregometer as a percentage. Data shown below represent the maximum platelet aggregation value obtained at baseline minus the maximum platelet aggregation value obtained after clopidogrel administration. Thus, values recorded below represent changes from baseline at day 8 and the unit is percent maximum aggregation. Higher reported values represent a greater reduction in platelet aggregation while lower reported values signify a smaller reduction in platelet aggregation when comparing baseline and post-clopidogrel visits.
Measured: 8 days of exposure to clopidogrel (change from baseline at day 8 reported)
Change in Maximal Platelet Aggregation in Response to Ticagrelor
Ex vivo platelet aggregometry was performed in platelet rich plasma (PRP) after stimulation with 20 μM adenosine diphosphate (ADP) at 2 time points (at baseline prior to drug administration and on the 8th day of ticagrelor [90 mg twice daily]). Maximum platelet aggregation is recorded by the platelet aggregometer as a percentage. Data shown below represent the maximum platelet aggregation value obtained at baseline minus the maximum platelet aggregation value obtained after ticagrelor administration. Thus, values recorded below represent changes from baseline at day 8 and the unit is percent maximum aggregation. Higher reported values represent a greater reduction in platelet aggregation while lower reported values signify a smaller reduction in platelet aggregation when comparing baseline and post-ticagrelor visits.
Measured: 8 days of independent exposure to ticagrelor (change from baseline at day 8 reported)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 201712 Dec 2022

First posted22 May 2017
Study start22 Aug 2017
Primary completion12 Dec 2022
Study completion12 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe 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 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Ninety healthy Amish subjects (30 CES1 G143E allele carriers, 30 carriers of a risk variant to be determined, and 30 age/sex-matched controls) will be enrolled. We will prospectively evaluate the effect of CES1 genotype on clopidogrel and ticagrelor response, as assessed by agonist-stimulated platelet aggregation, through the completion of a randomized crossover study of clopidogrel (75 mg per day for 7 d) and ticagrelor (90 mg twice daily for 7 d) in 90 healthy Amish individuals stratified by CES1 genotype as described above, with at least a 14-day washout period between drug interventions.
Masking: None (open label)
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03161678
Sponsor's protocol ID: HP-00074967
Status last verified: Jul 2026
First submitted: 18 May 2017
Last updated: 24 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: It is possible that deidentified data will be deposited into large public databases as per NIH data sharing policies (e.g. database of Genotypes and Phenotypes \[dbGAP\], Pharmacogenomics Knowledgebase \[PharmGKB\]). Data to be shared would include, but not limited to, anthropometric data, study outcome data, and relevant covariate data used in statistical models of association. It is anticipated that data would be available after the completion of the trial. The data will be obtained from the participants and the study-related research procedures.

Publications

Lewis JP, Ryan KA, Streeten EA, Whitlatch HB, Daue M, Tanner K, Perry JA, O'Connell JR, Shuldiner AR, Mitchell BD. Randomized evaluation of the loss-of-function carboxylesterase 1 (CES1) G143E variant on clopidogrel and ticagrelor pharmacodynamics. Clin Transl Sci. 2024 Nov;17(11):e70079. doi: 10.1111/cts.70079.
PubMed 39576732

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
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All Myocardial Infarction trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Genetic Variation in CES1 on Antiplatelet Therapy
ClinicalTrials.gov ID: NCT03161678
Acronym / sponsor ID: HP-00074967
Conditions: Myocardial Infarction, Thrombosis, Platelet Dysfunction
Keywords: Pharmacogenetics, Carboxylesterase 1 (CES1), Antiplatelet therapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 111 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Study start: 22 Aug 2017 (actual)
Primary completion: 12 Dec 2022 (actual)
Study completion: 12 Dec 2022 (actual)
First posted: 22 May 2017 (actual)
Results: Posted 6 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
Model description: Ninety healthy Amish subjects (30 CES1 G143E allele carriers, 30 carriers of a risk variant to be determined, and 30 age/sex-matched controls) will be enrolled. We will prospectively evaluate the effect of CES1 genotype on clopidogrel and ticagrelor response, as assessed by agonist-stimulated platelet aggregation, through the completion of a randomized crossover study of clopidogrel (75 mg per day for 7 d) and ticagrelor (90 mg twice daily for 7 d) in 90 healthy Amish individuals stratified by CES1 genotype as described above, with at least a 14-day washout period between drug interventions.

Arm	Type	Receives
Wild-Type Genotype	Active comparator	Drug: Clopidogrel, Drug: TicagrelorResearch subjects with wild type CES1 genotypes will be studied before and after oral ingestion of clopidogrel (75 mg/d for 8 days) and ticagrelor (90 mg twice daily for 8 days) treatment.
Carriers of the CES1 G143E Mutation	Experimental	Drug: Clopidogrel, Drug: TicagrelorResearch subjects who carry the CES1 G143E allele (rs71647871) will be studied before and after oral ingestion of clopidogrel (75 mg/d for 8 days) and ticagrelor (90 mg twice daily for 8 days) treatment.
Carriers of CES1 rs7498748 Mutation	Experimental	Drug: Clopidogrel, Drug: TicagrelorResearch subjects who carry a CES1 rs7498748 minor allele will be studied before and after oral ingestion of clopidogrel (75 mg/d for 8 days) and ticagrelor (90 mg twice daily for 8 days) treatment.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Of Amish descent
Age 18 to 75 years
Participant in the Phamacogenomics of Anti-Platelet Intervention (PAPI-1) Study or other Amish Research Center study, or a family member of an Amish Research Center study participant.

Key exclusion criteria (18 listed)

Clopidogrel or ticagrelor allergy
Platelet count < 100,000 mm3 or > 500,000 mm3
Hematocrit (Hct) < 32% or > 50%
Blood pressure > 160/95 mm Hg
Co-existing malignancy

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: PlavixClopidogrel (75 mg/d for 8 days) will be administered. Measures of pharmacodynamics will be assessed pre- and post-drug administration.	Drug	Carriers of CES1 rs7498748 Mutation, Carriers of the CES1 G143E Mutation, Wild-Type Genotype
TicagrelorAlso: BrilintaTicagrelor (90 mg twice daily for 8 days) will be administered. Measures of pharmacodynamics will be assessed pre- and post-drug administration.	Drug	Carriers of CES1 rs7498748 Mutation, Carriers of the CES1 G143E Mutation, Wild-Type Genotype

Primary outcome

Change in Maximal Platelet Aggregation in Response to Clopidogrel
Time frame: 8 days of exposure to clopidogrel (change from baseline at day 8 reported)
Ex vivo platelet aggregometry was performed in platelet rich plasma (PRP) after stimulation with 20 μM adenosine diphosphate (ADP) at 2 time points (at baseline prior to drug administration and on the 8th day of clopidogrel [75mg/d]). Maximum platelet aggregation is recorded by the platelet aggregometer as a percentage. Data shown below represent the maximum platelet aggregation value obtained at baseline minus the maximum platelet aggregation value obtained after clopidogrel administration. Thus, values recorded below represent changes from baseline at day 8 and the unit is percent maximum aggregation. Higher reported values represent a greater reduction in platelet aggregation while lower reported values signify a smaller reduction in platelet aggregation when comparing baseline and post-clopidogrel visits.
Change in Maximal Platelet Aggregation in Response to Ticagrelor
Time frame: 8 days of independent exposure to ticagrelor (change from baseline at day 8 reported)
Ex vivo platelet aggregometry was performed in platelet rich plasma (PRP) after stimulation with 20 μM adenosine diphosphate (ADP) at 2 time points (at baseline prior to drug administration and on the 8th day of ticagrelor [90 mg twice daily]). Maximum platelet aggregation is recorded by the platelet aggregometer as a percentage. Data shown below represent the maximum platelet aggregation value obtained at baseline minus the maximum platelet aggregation value obtained after ticagrelor administration. Thus, values recorded below represent changes from baseline at day 8 and the unit is percent maximum aggregation. Higher reported values represent a greater reduction in platelet aggregation while lower reported values signify a smaller reduction in platelet aggregation when comparing baseline and post-ticagrelor visits.

Results and safety

Results posted to the registry on 6 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Wild-Type Genotype: Clopidogrel First, Then Ticagrelor	17	16
Wild Type Genotype: Ticagrelor First, Then Clopidogrel	19	18
Carboxylesterase 1 (CES1) G143E Mutation: Clopidogrel First, Then Ticagrelor	10	10
Carboxylesterase 1 (CES1) G143E Mutation: Ticagrelor First, Then Clopidogrel	12	9
Carboxylesterase 1 (CES1) Functional Mutation: Clopidogrel First, Then Ticagrelor	23	22
Carboxylesterase 1 (CES1) Functional Mutation: Ticagrelor First, Then Clopidogrel	19	19

Primary outcome: Change in Maximal Platelet Aggregation in Response to Clopidogrel

Time frame: 8 days of exposure to clopidogrel (change from baseline at day 8 reported). Mean (Standard Error). Unit: Percent Maximal Platelet Aggregation

Measure	Wild-Type Genotype n = 34	Carriers of the CES1 G143E Mutation n = 17	Carriers of CES1 Functional Mutation n = 38
Value	32.6 (2.7)	50.8 (2.1)	35.0 (2.1)

Wild-Type Genotype vs Carriers of the CES1 G143E Mutation: p <0.001, Regression, Linear
Wild-Type Genotype vs Carriers of CES1 Functional Mutation: p = 0.24, Regression, Linear

Population analysed: All of the outcome measures in this trial were pre-specified to be analyzed by genotype. Therefore, Arm/Groups are shown by genotype group rather than per medication sequence order. This is consistent with how baseline characteristics are displayed as well.

Primary outcome: Change in Maximal Platelet Aggregation in Response to Ticagrelor

Time frame: 8 days of independent exposure to ticagrelor (change from baseline at day 8 reported). Mean (Standard Error). Unit: Percent Maximal Platelet Aggregation

Measure	Wild-Type Genotype n = 34	Carriers of the CES1 G143E Mutation n = 17	Carriers of CES1 Functional Mutation n = 38
Value	46.1 (1.5)	47.8 (1.8)	39.6 (1.9)

Wild-Type Genotype vs Carriers of the CES1 G143E Mutation: p = 0.75, Regression, Linear
Wild-Type Genotype vs Carriers of CES1 Functional Mutation: p = 0.011, Regression, Linear

Adverse events

Time frame: During both intervention periods, the washout period, and for 30 days after the final study visit, up to 57 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Wild-Type Genotype: Clopidogrel	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Wild Type Genotype: Ticagrelor	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Carboxylesterase 1 (CES1) G143E Mutation: Clopidogrel	0 of 19 (0%)	1 of 19 (5.3%)	0 of 19
Carboxylesterase 1 (CES1) G143E Mutation: Ticagrelor	0 of 21 (0%)	1 of 21 (4.8%)	0 of 21
Carboxylesterase 1 (CES1) Functional Mutation: Clopidogrel	0 of 41 (0%)	0 of 41 (0%)	0 of 41
Carboxylesterase 1 (CES1) Functional Mutation: Ticagrelor	0 of 39 (0%)	0 of 39 (0%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39576732Lewis JP, Ryan KA, Streeten EA, Whitlatch HB, Daue M, Tanner K, Perry JA, O'Connell JR, Shuldiner AR, Mitchell BD. Randomized evaluation of the loss-of-function carboxylesterase 1 (CES1) G143E variant on clopidogrel and ticagrelor pharmacodynamics. Clin Transl Sci. 2024 Nov;17(11):e70079. doi: 10.1111/cts.70079.
Individual participant dataSharing planned: Yes. It is possible that deidentified data will be deposited into large public databases as per NIH data sharing policies (e.g. database of Genotypes and Phenotypes [dbGAP], Pharmacogenomics Knowledgebase [PharmGKB]). Data to be shared would include, but not limited to, anthropometric data, study outcome data, and relevant covariate data used in statistical models of association. It is anticipated that data would be available after the completion of the trial. The data will be obtained from the participants and the study-related research procedures.

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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.

Braxton D Mitchell, PhD principal investigator

University of Maryland

1 site 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 in people with Myocardial Infarction and Thrombosis, run by University of Maryland, Baltimore 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 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: finished, as of the sponsor's last update on 24 Jul 2026. 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.

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?

Yes. Results are posted in the registry (first posted 6 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Maximal Platelet Aggregation in Response to Clopidogrel (time frame: 8 days of exposure to clopidogrel (change from baseline at day 8 reported)). The study lists 2 primary outcomes in all. 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 NCT03161678, 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 24 Jul 2026.