Acute Coronary Syndrome (ACS)Phase 4NCT04116931
OPTImal Management of Antithrombotic Agents: OPTIMA-5
A Phase 4 study testing Switch ticagrelor to clopidogrel in people with Acute Coronary Syndrome (ACS), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is a prospective, randomized, open-label clinical trial which will enroll 80 acute coronary syndrome (ACS) patients after Percutaneous Transluminal Coronary Intervention (PCI) in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome (ACS)
- What is being tested?
- Switch ticagrelor to clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2020to 30 Jun 2021
- 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
- ≥ 18 years.
- ACS patients.
- Patients who are treated with ticagrelor and do not tolerate it.
- Volunteer to participate and sign informed consent.
- Approved by national regulatory authorities ethics committees.
Who cannot join
- Patients who are contraindicated, intolerant or resistant to clopidogrel.
- History of hematological disease or bleeding tendency; platelet count < 100 × 10^9 cells/L, or > 600 × 10^9 cells/L, hemoglobin < 100 g/L.
- Abnormal liver or kidney function (ALT > 3 ULN; estimated CrCl < 30 ml/min calculated by Cockcroft-Gault equation); diagnosed severe pulmonary disease.
- Patients in need of drugs which affect the efficacy of clopidogrel such as miconazole, ketoconazole, andfluconazole.
- Malignancies or other comorbid conditions with life expectancy less than 1 year.
- Pregnant or lactating woman.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Fuming Zhang, M.D., +86-25-83718836 ext. 6360, jsphkj@163.com
Yi Chai, M.D., +86-25-83718836 ext. 6360, jsphkj@163.com
About this study
Official title: A Randomized Controlled Trial on the Switch From Ticagrelor to Clopidogrel in Acute Coronary Syndrome Patients After Percutaneous Coronary Intervention--OPTImal Management of Antithrombotic Agents: OPTIMA-5
This is a prospective, randomized, open-label clinical trial which will enroll 80 acute coronary syndrome (ACS) patients after Percutaneous Transluminal Coronary Intervention (PCI) in China. Patients on maintenance dosing (MD) of aspirin (100 mg/d) and ticagrelor (90 mg twice daily) will be divided into two groups switching from ongoing ticagrelor to clopidogrel 600 mg loading dose (LD)/ 75 mg MD according to their bleeding risk. Then each group will randomly switch at different times(24 hours/ 12 hours after the last MD of ticagrelor). Pharmacodynamic assessments are performed at baseline, and at 4h, 8h, 24h, 48h, 72h hours with platelet aggregation rate by Light Transmittance Aggregometry method (LTA). All patients are followed-up for 30 days.
Read the detailed description
The primary endpoint of the study was platelet inhibition measured by Light Transmittance Aggregometry method(LTA). Secondary clinical endpoints included a 30-day major adverse cardiovascular endpoint (MACE) defined as a composite of cardiovascular death, recurrent myocardial infarction, target vessel revascularisation or stroke and individual components of the MACE. Safety endpoints of 30-day TIMI major and minor bleed were also evaluated.
- Conditions
- Acute Coronary Syndrome (ACS)
- Being tested
- Switch ticagrelor to clopidogrel
- Keywords
- Dual antiplatelet therapy (DAPT), Platelet function, Clopidogrel, Ticagrelor, Switch
- 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.
Switch ticagrelor to clopidogrelDrug
Also called switch
Switch ticagrelor to clopidogrel with 600 mg loading dose (LD)/75 mg maintenance dose（MD）12/24 hours after the last MD of ticagrelor
| Study group | Role | What they receive |
|---|---|---|
| clopidogrel-600 mg-12h | Experimental | clopidogrel 600 mg loading dose (LD) 12 hours after the last maintenance dose（MD） of ticagrelor followed by 75 mg MD daily Receives: Drug: Switch ticagrelor to clopidogrel |
| clopidogrel-600 mg-24h | Experimental | clopidogrel 600 mg loading dose (LD) 24 hours after the last maintenance dose（MD） of ticagrelor followed by 75 mg MD daily Receives: Drug: Switch ticagrelor to clopidogrel |
| clopidogrel-75 mg-12h | Experimental | clopidogrel 75 mg maintenance dose(MD) 12 hours after the last MD of ticagrelor Receives: Drug: Switch ticagrelor to clopidogrel |
| clopidogrel-75 mg-24h | Experimental | clopidogrel 75 mg maintenance dose（MD) 24 hours after the last MD of ticagrelor Receives: Drug: Switch ticagrelor to clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of platelet aggregation between different time points
Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).
Measured: baseline,4 hours,8 hours,24 hours,48 hours,72 hours
Secondary outcomes (1)
Rate of clinical endpoint event
Secondary clinical endpoints included a 30-day major adverse cardiovascular endpoint (MACE) defined as a composite of cardiovascular death, recurrent myocardial infarction, target vessel revascularisation or stroke and individual components of the MACE. Safety endpoints of 30-day TIMI major and minor bleed were also evaluated.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start22 Jun 2020
- Primary completion30 May 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndrome (ACS)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjian Li, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Chunjian Li, Dr, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116931
- Sponsor's protocol ID
- 011
- Status last verified
- Aug 2020
- First submitted
- 26 Sep 2019
- Last updated
- 25 Aug 2020
- 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 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Switch From Ticagrelor to Clopidogrel in Acute Coronary Syndrome Patients After Percutaneous Coronary Intervention--OPTImal Management of Antithrombotic Agents: OPTIMA-5
- ClinicalTrials.gov ID
- NCT04116931
- Acronym / sponsor ID
- 011
- Conditions
- Acute Coronary Syndrome (ACS)
- Keywords
- Dual antiplatelet therapy (DAPT), Platelet function, Clopidogrel, Ticagrelor, Switch
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 7 Oct 2019 (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.
This is a prospective, randomized, open-label clinical trial which will enroll 80 acute coronary syndrome (ACS) patients after Percutaneous Transluminal Coronary Intervention (PCI) in China. Patients on maintenance dosing (MD) of aspirin (100 mg/d) and ticagrelor (90 mg twice daily) will be divided into two groups switching from ongoing ticagrelor to clopidogrel 600 mg loading dose (LD)/ 75 mg MD according to their bleeding risk. Then each group will randomly switch at different times(24 hours/ 12 hours after the last MD of ticagrelor). Pharmacodynamic assessments are performed at baseline, and at 4h, 8h, 24h, 48h, 72h hours with platelet aggregation rate by Light Transmittance Aggregometry method (LTA). All patients are followed-up for 30 days.
Detailed description
The primary endpoint of the study was platelet inhibition measured by Light Transmittance Aggregometry method(LTA). Secondary clinical endpoints included a 30-day major adverse cardiovascular endpoint (MACE) defined as a composite of cardiovascular death, recurrent myocardial infarction, target vessel revascularisation or stroke and individual components of the MACE. Safety endpoints of 30-day TIMI major and minor bleed were also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| clopidogrel-600 mg-12h | Experimental | Drug: Switch ticagrelor to clopidogrelclopidogrel 600 mg loading dose (LD) 12 hours after the last maintenance dose（MD） of ticagrelor followed by 75 mg MD daily |
| clopidogrel-600 mg-24h | Experimental | Drug: Switch ticagrelor to clopidogrelclopidogrel 600 mg loading dose (LD) 24 hours after the last maintenance dose（MD） of ticagrelor followed by 75 mg MD daily |
| clopidogrel-75 mg-12h | Experimental | Drug: Switch ticagrelor to clopidogrelclopidogrel 75 mg maintenance dose(MD) 12 hours after the last MD of ticagrelor |
| clopidogrel-75 mg-24h | Experimental | Drug: Switch ticagrelor to clopidogrelclopidogrel 75 mg maintenance dose（MD) 24 hours after the last MD of ticagrelor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years.
- ACS patients.
- Patients who are treated with ticagrelor and do not tolerate it.
- Volunteer to participate and sign informed consent.
- Approved by national regulatory authorities ethics committees.
Key exclusion criteria (6 listed)
- Patients who are contraindicated, intolerant or resistant to clopidogrel.
- History of hematological disease or bleeding tendency; platelet count < 100 × 10^9 cells/L, or > 600 × 10^9 cells/L, hemoglobin < 100 g/L.
- Abnormal liver or kidney function (ALT > 3 ULN; estimated CrCl < 30 ml/min calculated by Cockcroft-Gault equation); diagnosed severe pulmonary disease.
- Patients in need of drugs which affect the efficacy of clopidogrel such as miconazole, ketoconazole, andfluconazole.
- Malignancies or other comorbid conditions with life expectancy less than 1 year.
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 |
|---|---|---|
| Switch ticagrelor to clopidogrelAlso: switchSwitch ticagrelor to clopidogrel with 600 mg loading dose (LD)/75 mg maintenance dose（MD）12/24 hours after the last MD of ticagrelor | Drug | clopidogrel-600 mg-12h, clopidogrel-600 mg-24h, clopidogrel-75 mg-12h, clopidogrel-75 mg-24h |
Primary outcome
Change of platelet aggregation between different time points
Time frame: baseline,4 hours,8 hours,24 hours,48 hours,72 hours
Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).
1 secondary outcome
Rate of clinical endpoint event
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- 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.
Chunjian Li, Dr, PhD principal investigator
Principal Investigator
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 Switch ticagrelor to clopidogrel in people with Acute Coronary Syndrome (ACS), run by The First Affiliated Hospital with Nanjing Medical University 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 6 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 25 Aug 2020. 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 Chunjian Li, Dr, PhD (+86-13701465229, drcjli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of platelet aggregation between different time points (time frame: baseline,4 hours,8 hours,24 hours,48 hours,72 hours). 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 25 Aug 2020.