Acute Coronary SyndromePhase 2OPTIMANCT02319941
Comparison of Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients With Acute Coronary Syndromes
A Phase 2 study testing ticagrelor and clopidogrel in people with Acute Coronary Syndrome, run by Seung-Jung Park at 1 site in South Korea.
Trial summary
The purpose of this study is to compare Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients with Acute Coronary Syndromes Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- ticagrelor and clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 May 2015to 10 Mar 2017
- Phase
- Phase 2
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ST elevation or non ST elevation acute coronary syndrome patients of chest pain within 24 hours
Who cannot join
- Known hypersensitivity to clopidogrel and ticagrelor and aspirin
- Treatment with anticoagulants
- Exposure to a thrombolytic agent within 24 hours prior to randomization
- Use of glycoprotein IIb - IIIa inhibitors at randomization
- History of major hemorrhage (intracranial, gastrointestinal, etc.)
- clotting disorder and/or bleeding disorder
Show all 16Show fewer
- Any history of Severe renal or hepatic dysfunction
- Hematologic disorder including a Hemoglobin less than 10 g/L or a platelet count less than 80,000 cells/mm3
- Cardiac shock, severe left ventricular dysfunction LVEF less than 30%
- Sick sinus syndrome or second degree of av block without permanent pacemaker
- No concurrent cytochrome p450 3a inhibitors and enhancers within 2 weeks
- Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg,drug and alcohol abuse, mental illness) or that could prevent, limit, or confound the protocol-specified assessments.
- Life expectancy of less than 6 months
- Pregnancy or lactating
- Participation in any drug study in the previous 3 months
- Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients With Acute Coronary Syndromes; Pharmacodynamics and Pharmacokinetics Study
The purpose of this study is to compare Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients with Acute Coronary Syndromes
- Conditions
- Acute Coronary Syndrome
- Being tested
- ticagrelor, clopidogrel
- Keywords
- Inhibition of Platelet Reactivity, ticagrelor, clopidogrel, Pharmacodynamics, Pharmacokinetics
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelorDrug
clopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| Low dose ticagrelor | Experimental | 60mg bid Receives: Drug: ticagrelor |
| standard dose ticagrelor | Active comparator | 90mg bid Receives: Drug: ticagrelor |
| standard dose clopidogrel | Active comparator | 75mg qd Receives: Drug: clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
P2Y12 reaction units(PRU)
P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay
Measured: 8 hours and 30days after first randomized dose
Secondary outcomes (7)
Percentage inhibition of platelet aggregation
Measured: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
Aggregation units(AU), Area Under the Curve(AUC)
by Multiplate analyzer
Measured: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
Percentage of low-responsive patients
Low-responsive patients is defined as PRU ≥ 235 from VerifyNow P2Y12 and/or percentage of platelet inhibition <15%
Measured: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
Description of the pharmacokinetic (PK) profile for Ticagrelor and its metabolite AR-C124910XX
in terms of maximum concentration (Cmax),time to maximum concentration (tmax) and area under the concentration curve from time zero to infinity (AUC), t1/2, CL/F
Measured: 0, 0.5, 1, 2, 4, 8, 10,24 hours after first randomized study treatment
MACE(Major adverse cardiac event)
Death, Myocardial Infarction, stent thrombosis, stroke,
Measured: 30 days after first randomized study treatment
Adverse event
including bleeding by TIMI/PLATO criteria, dyspnea, bradycardia, syncope,
Measured: 30 days after first randomized study treatment
Drug tolerance
Drug tolerance is evaluated as adverse event following discontinuation of drug administration
Measured: 30 days after first randomized study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study start20 May 2015
- Primary completion14 Feb 2017
- Study completion10 Mar 2017
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 Acute Coronary SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Roche Pharma AG, KBM pharm
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319941
- Sponsor's protocol ID
- AMCCV2014-07
- Acronym
- OPTIMA
- Status last verified
- Jun 2017
- First submitted
- 15 Dec 2014
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park DW, Lee PH, Jang S, Lim HS, Kang DY, Lee CH, Ahn JM, Yun SC, Park SW, Park SJ. Effect of Low-Dose Versus Standard-Dose Ticagrelor and Clopidogrel on Platelet Inhibition in Acute Coronary Syndromes. J Am Coll Cardiol. 2018 Apr 10;71(14):1594-1595. doi: 10.1016/j.jacc.2018.02.010. No abstract available.
PubMed 29622168
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients With Acute Coronary Syndromes; Pharmacodynamics and Pharmacokinetics Study
- ClinicalTrials.gov ID
- NCT02319941
- Acronym / sponsor ID
- OPTIMA / AMCCV2014-07
- Conditions
- Acute Coronary Syndrome
- Keywords
- Inhibition of Platelet Reactivity, ticagrelor, clopidogrel, Pharmacodynamics, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- AstraZeneca, Roche Pharma AG, KBM pharm
- Study start
- 20 May 2015 (actual)
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 18 Dec 2014 (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 purpose of this study is to compare Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients with Acute Coronary Syndromes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose ticagrelor | Experimental | Drug: ticagrelor60mg bid |
| standard dose ticagrelor | Active comparator | Drug: ticagrelor90mg bid |
| standard dose clopidogrel | Active comparator | Drug: clopidogrel75mg qd |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ST elevation or non ST elevation acute coronary syndrome patients of chest pain within 24 hours
Key exclusion criteria (16 listed)
- Known hypersensitivity to clopidogrel and ticagrelor and aspirin
- Treatment with anticoagulants
- Exposure to a thrombolytic agent within 24 hours prior to randomization
- Use of glycoprotein IIb - IIIa inhibitors at randomization
- History of major hemorrhage (intracranial, gastrointestinal, etc.)
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 |
|---|---|---|
| ticagrelor | Drug | Low dose ticagrelor, standard dose ticagrelor |
| clopidogrel | Drug | standard dose clopidogrel |
Primary outcome
P2Y12 reaction units(PRU)
Time frame: 8 hours and 30days after first randomized dose
P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay
7 secondary outcomes
Percentage inhibition of platelet aggregation
Time frame: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
Aggregation units(AU), Area Under the Curve(AUC)
Time frame: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
Percentage of low-responsive patients
Time frame: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
Description of the pharmacokinetic (PK) profile for Ticagrelor and its metabolite AR-C124910XX
Time frame: 0, 0.5, 1, 2, 4, 8, 10,24 hours after first randomized study treatment
MACE(Major adverse cardiac event)
Time frame: 30 days after first randomized study treatment
Adverse event
Time frame: 30 days after first randomized study treatment
Drug tolerance
Time frame: 30 days after first randomized study treatment
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 16 Jun 2017.
- Derived from this study: PubMed 29622168Park DW, Lee PH, Jang S, Lim HS, Kang DY, Lee CH, Ahn JM, Yun SC, Park SW, Park SJ. Effect of Low-Dose Versus Standard-Dose Ticagrelor and Clopidogrel on Platelet Inhibition in Acute Coronary Syndromes. J Am Coll Cardiol. 2018 Apr 10;71(14):1594-1595. doi: 10.1016/j.jacc.2018.02.010. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ticagrelor and clopidogrel in people with Acute Coronary Syndrome, run by Seung-Jung Park at 1 site in South Korea.
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 16 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 16 Jun 2017. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
P2Y12 reaction units(PRU) (time frame: 8 hours and 30days after first randomized dose). 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 NCT02319941, 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 16 Jun 2017.