Non ST Segment Elevation Acute Coronary SyndromePhase 4OPT-CKDNCT02578537
COmparison of the Pharmacodynamics and Pharmacokinetics Ticagrelor Versus Clopidogrel in Patients With CKD and NSTE-ACS
A Phase 4 study testing Ticagrelor and Clopidogrel in people with Non ST Segment Elevation Acute Coronary Syndrome and Chronic Kidney Disease, run by Shenyang Northern Hospital at 1 site in China.
Trial summary
Ticagrelor, a new P2Y12 receptor antagonist, achieve faster, consistent and higher platelet inhibition than clopidogrel, which was considered more noticeable in patients with ACS combining chronic kidney disease(CKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non ST Segment Elevation Acute Coronary Syndrome, Chronic Kidney Disease
- What is being tested?
- Ticagrelor and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- P2Y12 inhibitor naïve patients presenting with NSTE-ACS (unstable angina or non-ST segment elevation myocardial infarction).
- Males and non-pregnant females > 18 years of age.
- eGFR<60 ml/min/1.73m2 (MRDR formula).
- With planned percutaneous coronary intervention(PCI will be performed over 24 hours after loading dose).
- Written informed consent provided.Provision of informed consent prior to any study specific procedures.
Who cannot join
- Cardiogenic shock.
- Thrombolytic therapy administered before randomization.
- Active bleeding or bleeding predisposition, including the retinal or vitreous hemorrhage , gastrointestinal or urinary tract hemorrhage , history of intracranial haemorrhage or cerebral infarction .
- Hypersensitivity to ticagrelor or any excipients.
- Deep puncture or major surgery within 1 month.
- Untreated or uncontrolled hypertension with blood pressure >180/110 mmHg.
Show all 14Show fewer
- Known hemoglobin <10 g/dL or platelet count <100 × 109/L.
- Known moderate or severe hepatic impairment.
- Known aminotransferase level >3x the upper limit of normal.
- Known allergy to any of the study drugs or devices (aspirin, clopidogrel, ticagrelor stainless steel, contrast agents, etc.).
- Pregnancy or lactation.
- Any condition which might interfere with study compliance, or otherwise unsuitable for study participation as judged by the investigators.
- Unwilling or unable to get repeat platelet assay or clinical follow-up.
- Unwilling or unable to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenyang Northern Hospital
Shenyang, Liaoning, 110016
Yaling Han, MD,PHD, 86-024-28856123, hanyaling@263.net
Yi Li, MD, 86-024-28897309, doctorliyi@126.com
About this study
Official title: COmparison of the Pharmacodynamics and Pharmacokinetics of Ticagrelor Versus Clopidogrel in Patients With Chronic Kidney Disease and Non-ST-Elevation Acute Coronary Syndromes(OPT-CKD Trial)
Ticagrelor, a new P2Y12 receptor antagonist, achieve faster, consistent and higher platelet inhibition than clopidogrel, which was considered more noticeable in patients with ACS combining chronic kidney disease(CKD). Nonetheless, the pharmacokinetic properties of ticagrelor in the patients with CKD and NSTE-ACS has not been thoroughly studied. This study was designed to provide PK and PD data of ticagrelor compared with clopidogrel, in order to estimate that ticagrelor is superior to clopidogrel in getting better inhibition of platelet in patients with CKD and NSTE-ACS. P2Y12 inhibitor naïve patients with CKD (eGFR < 60 ml/min/1.73m2 ) and NSTE-ACS will be enrolled in this single-center, prospective, randomized, parallel-control study and randomly assigned in a one-to-one ratio to receive ticagrelor or clopidogrel on top of chronic aspirin treatment. The primary endpoint was the PRU by Verify Now at 30 days after loading dose.
Read the detailed description
Dual antiplatelet therapy with aspirin and clopidogrel has become the standard care in patients with acute coronary syndrome (ACS). However, clopidogrel is being questioned for its insufficient platelet inhibition and residual platelet reactivity, especially in patients with impaired renal function. Ticagrelor, a new P2Y12 receptor antagonist, achieve faster, consistent and higher platelet inhibition than clopidogrel, which was more noticeable in patients with ACS combining chronic kidney disease(CKD). Nonetheless, the pharmacokinetic properties of ticagrelor in the patients with CKD and NSTE-ACS, to the best of the investigators' knowledge, has not been thoroughly studied. This study was designed to provide PK and PD data of ticagrelor compared with clopidogrel, in order to estimate that ticagrelor is superior to clopidogrel in getting better inhibition of platelet in patients with CKD and NSTE-ACS. The potential hypothesis is to evaluate the correlation of platelet inhibition and renal function and CYP2C19 gene type in patients treated by ticagrelor and clopidogrel. P2Y12 inhibitor naïve patients with CKD (eGFR < 60 ml/min/1.73m2 ) and NSTE-ACS will be enrolled in this single-center, prospective, randomized, parallel study and randomly assigned in a one-to-one ratio to receive ticagrelor or clopidogrel on top of chronic aspirin treatment. The primary endpoint was the PRU by Verify Now at 30 days after loading dose.
- Being tested
- Ticagrelor, Clopidogrel
- Keywords
- Ticagrelor, Pharmacokinetics, NSTE-ACS, CKD
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brilinta
Ticagrelor group:all patients receive ticagrelor (180 mg loading dose, then 90 mg twice daily followed for 30 days). All patients were given aspirin 100 mg per day unless they were intolerant. For those not previously given aspirin, a loading dose of 300 mg was preferred.
ClopidogrelDrug
Also called Plavix
Clopidogrel group:all patients receive clopidogrel (600 mg loading dose, then 75 mg once daily followed for 30 days). All patients were given aspirin 100 mg per day unless they were intolerant. For those not previously given aspirin, a loading dose of 300 mg was preferred.
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor group | Experimental | ticagrelor 180mg loading, followed by 90mg bid for 30 days Receives: Drug: Ticagrelor |
| Clopidogrel group | Active comparator | clopidogrel 600mg loading, followed by 75mg/d for 30 days Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRU assayed by VerifyNow
Measured: 30 days after loading does of study drug
Secondary outcomes (5)
PRU assayed by VerifyNow
Measured: at the time of pre-dose, and 2 hours, 8 hours, and 24 hours after loading dose of study durg.
Index of Platelet activity
calculated by the change of the P2Y12 reaction units (PRU) from baseline
Measured: at the time of 2 hours, 8 hours, and 24 hours after loading dose of study drug
Rate of high on-treatment platelet reactivity (HPR)
Measured: at the time of pre-dose, and 2 hours, 8 hours, 24 hours and 30 days after loading dose of study durg.
Plasma concentration of ticagrelor and clopidogrel
Measured: at 2 hours, 8 hours, and 24 hours after loading dose of study durg.
Bleeding events
by BARC classification
Measured: 30 days after loading does of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2016 (estimated)
- Study completionJul 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 Non ST Segment Elevation 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
- Investigators
- Yaling Han, MD, Principal investigator, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578537
- Sponsor's protocol ID
- ESR-14-10607
- Acronym
- OPT-CKD
- Status last verified
- Dec 2015
- First submitted
- 15 Oct 2015
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
PubMed 35224730
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmparison of the Pharmacodynamics and Pharmacokinetics of Ticagrelor Versus Clopidogrel in Patients With Chronic Kidney Disease and Non-ST-Elevation Acute Coronary Syndromes(OPT-CKD Trial)
- ClinicalTrials.gov ID
- NCT02578537
- Acronym / sponsor ID
- OPT-CKD / ESR-14-10607
- Keywords
- Ticagrelor, Pharmacokinetics, NSTE-ACS, CKD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 19 Oct 2015 (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.
Ticagrelor, a new P2Y12 receptor antagonist, achieve faster, consistent and higher platelet inhibition than clopidogrel, which was considered more noticeable in patients with ACS combining chronic kidney disease(CKD). Nonetheless, the pharmacokinetic properties of ticagrelor in the patients with CKD and NSTE-ACS has not been thoroughly studied. This study was designed to provide PK and PD data of ticagrelor compared with clopidogrel, in order to estimate that ticagrelor is superior to clopidogrel in getting better inhibition of platelet in patients with CKD and NSTE-ACS. P2Y12 inhibitor naïve patients with CKD (eGFR < 60 ml/min/1.73m2 ) and NSTE-ACS will be enrolled in this single-center, prospective, randomized, parallel-control study and randomly assigned in a one-to-one ratio to receive ticagrelor or clopidogrel on top of chronic aspirin treatment. The primary endpoint was the PRU by Verify Now at 30 days after loading dose.
Detailed description
Dual antiplatelet therapy with aspirin and clopidogrel has become the standard care in patients with acute coronary syndrome (ACS). However, clopidogrel is being questioned for its insufficient platelet inhibition and residual platelet reactivity, especially in patients with impaired renal function. Ticagrelor, a new P2Y12 receptor antagonist, achieve faster, consistent and higher platelet inhibition than clopidogrel, which was more noticeable in patients with ACS combining chronic kidney disease(CKD). Nonetheless, the pharmacokinetic properties of ticagrelor in the patients with CKD and NSTE-ACS, to the best of the investigators' knowledge, has not been thoroughly studied. This study was designed to provide PK and PD data of ticagrelor compared with clopidogrel, in order to estimate that ticagrelor is superior to clopidogrel in getting better inhibition of platelet in patients with CKD and NSTE-ACS. The potential hypothesis is to evaluate the correlation of platelet inhibition and renal function and CYP2C19 gene type in patients treated by ticagrelor and clopidogrel. P2Y12 inhibitor naïve patients with CKD (eGFR < 60 ml/min/1.73m2 ) and NSTE-ACS will be enrolled in this single-center, prospective, randomized, parallel study and randomly assigned in a one-to-one ratio to receive ticagrelor or clopidogrel on top of chronic aspirin treatment. The primary endpoint was the PRU by Verify Now at 30 days after loading dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor group | Experimental | Drug: Ticagrelorticagrelor 180mg loading, followed by 90mg bid for 30 days |
| Clopidogrel group | Active comparator | Drug: Clopidogrelclopidogrel 600mg loading, followed by 75mg/d for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- P2Y12 inhibitor naïve patients presenting with NSTE-ACS (unstable angina or non-ST segment elevation myocardial infarction).
- Males and non-pregnant females > 18 years of age.
- eGFR<60 ml/min/1.73m2 (MRDR formula).
- With planned percutaneous coronary intervention(PCI will be performed over 24 hours after loading dose).
- Written informed consent provided.Provision of informed consent prior to any study specific procedures.
Key exclusion criteria (14 listed)
- Cardiogenic shock.
- Thrombolytic therapy administered before randomization.
- Active bleeding or bleeding predisposition, including the retinal or vitreous hemorrhage , gastrointestinal or urinary tract hemorrhage , history of intracranial haemorrhage or cerebral infarction .
- Hypersensitivity to ticagrelor or any excipients.
- Deep puncture or major surgery within 1 month.
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 |
|---|---|---|
| TicagrelorAlso: BrilintaTicagrelor group:all patients receive ticagrelor (180 mg loading dose, then 90 mg twice daily followed for 30 days). All patients were given aspirin 100 mg per day unless they were intolerant. For those not previously given aspirin, a loading dose of 300 mg was preferred. | Drug | Ticagrelor group |
| ClopidogrelAlso: PlavixClopidogrel group:all patients receive clopidogrel (600 mg loading dose, then 75 mg once daily followed for 30 days). All patients were given aspirin 100 mg per day unless they were intolerant. For those not previously given aspirin, a loading dose of 300 mg was preferred. | Drug | Clopidogrel group |
Primary outcome
PRU assayed by VerifyNow
Time frame: 30 days after loading does of study drug
5 secondary outcomes
PRU assayed by VerifyNow
Time frame: at the time of pre-dose, and 2 hours, 8 hours, and 24 hours after loading dose of study durg.
Index of Platelet activity
Time frame: at the time of 2 hours, 8 hours, and 24 hours after loading dose of study drug
Rate of high on-treatment platelet reactivity (HPR)
Time frame: at the time of pre-dose, and 2 hours, 8 hours, 24 hours and 30 days after loading dose of study durg.
Plasma concentration of ticagrelor and clopidogrel
Time frame: at 2 hours, 8 hours, and 24 hours after loading dose of study durg.
Bleeding events
Time frame: 30 days after loading does of study drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Derived from this study: PubMed 35224730Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
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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.
Yaling Han, MD principal investigator
General Hospital of Shenyang Military Region
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 Ticagrelor and Clopidogrel in people with Non ST Segment Elevation Acute Coronary Syndrome and Chronic Kidney Disease, run by Shenyang Northern Hospital at 1 site 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 5 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 11 Dec 2015. 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 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.
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 Heyang Wang, MD (86-024-28897309, whysmmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRU assayed by VerifyNow (time frame: 30 days after loading does of study drug). 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 NCT02578537, 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 11 Dec 2015.