Antiplatelet TherapyPhase 4LOTICNCT04060914
LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention
A Phase 4 study testing Ticagrelor 90mg, Ticagrelor 90mg/60mg and Clopidogrel 75mg in people with Antiplatelet Therapy and Coronary Artery Disease, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The hypothesis in this study was that ticagrelor switched to 60 mg after 1 month of standard dose, with antiplatelet activity that is not inferior to the standard dose and better than 75 mg clopidogrel for patients with ACS after PCI. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Antiplatelet Therapy, Coronary Artery Disease, Percutaneous Coronary Intervention
- What is being tested?
- Ticagrelor 90mg, Ticagrelor 90mg/60mg and Clopidogrel 75mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2019to 30 Dec 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agree to sign the Informed Consent;
- Male or female, ≥ 18 years of age, and ≤ 70 years of age
- Patient presents with acute coronary syndrome (ACS)
- Planned to undergo PCI
- Planned to DAPT for 1 year after PCI
Who cannot join
- Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit.
- Patients cannot use ticagrelor or clopidogrel due to contraindications or other reasons.
- Patients with active pathological hemorrhage or a history of intracranial hemorrhage
- 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
- Patient or physician refusal to enroll in the study
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- 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 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
- Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with ticagrelor
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Yang Lin, PhD, 86-010-64456609, linyang3623@outlook.com
Xiujing Shi, MD, 86-010-64456609, xiujingshi@163.com
About this study
The hypothesis in this study was that ticagrelor switched to 60 mg after 1 month of standard dose, with antiplatelet activity that is not inferior to the standard dose and better than 75 mg clopidogrel for patients with ACS after PCI.
- Being tested
- Ticagrelor 90mg, Ticagrelor 90mg/60mg, Clopidogrel 75mg
- Keywords
- ticagrelor, clopidogrel, Percutaneous Coronary Intervention, Coronary Artery Disease, Adenosine
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 90mgDrug
Ticagrelor 90 mg plus aspirin for 12 months
Ticagrelor 90mg/60mgDrug
1 month after treatment with ticagrelor 90 mg plus aspirin, followed by treatment with ticagrelor 60 mg plus aspirin for 11 months
Clopidogrel 75mgDrug
Clopidogrel 75mg plus aspirin for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor(90mg) | Experimental | Not described Receives: Drug: Ticagrelor 90mg |
| Ticagrelor(90/60mg) | Experimental | Not described Receives: Drug: Ticagrelor 90mg/60mg |
| Clopidogrel(75mg) | Active comparator | Not described Receives: Drug: Clopidogrel 75mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity index (PRI)
Platelet reactivity of ticagrelor or clopidogrel MD will be measured as PRI% using whole blood vasodilator-stimulated phosphoprotein (VASP) at 90 days after PCI.
Measured: 90 days (±14)
Secondary outcomes (3)
Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)
MACCE includes all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI), and ischemic-driven revascularization.
Measured: 1 year
The platelet aggregation ratio
Platelet aggregation of ticagrelor or clopidogrel MD will be measured using the Light Transmittance Aggregometry method at day 90 after PCI.
Measured: 90 days (±14)
Plasma adenosine concentration
Plasma adenosine concentration in the three treatment groups will be measured using the HPLC-MS at day 90 after PCI.
Measured: 90 days (±14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start30 Aug 2019 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiplatelet TherapyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Yang, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060914
- Sponsor's protocol ID
- ANZHEN HOSPITOL-LY-01
- Acronym
- LOTIC
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04060914
- Acronym / sponsor ID
- LOTIC / ANZHEN HOSPITOL-LY-01
- Keywords
- ticagrelor, clopidogrel, Percutaneous Coronary Intervention, Coronary Artery Disease, Adenosine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 30 Aug 2019 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 19 Aug 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.
The hypothesis in this study was that ticagrelor switched to 60 mg after 1 month of standard dose, with antiplatelet activity that is not inferior to the standard dose and better than 75 mg clopidogrel for patients with ACS after PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor(90mg) | Experimental | Drug: Ticagrelor 90mg |
| Ticagrelor(90/60mg) | Experimental | Drug: Ticagrelor 90mg/60mg |
| Clopidogrel(75mg) | Active comparator | Drug: Clopidogrel 75mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Agree to sign the Informed Consent;
- Male or female, ≥ 18 years of age, and ≤ 70 years of age
- Patient presents with acute coronary syndrome (ACS)
- Planned to undergo PCI
- Planned to DAPT for 1 year after PCI
Key exclusion criteria (17 listed)
- Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit.
- Patients cannot use ticagrelor or clopidogrel due to contraindications or other reasons.
- Patients with active pathological hemorrhage or a history of intracranial hemorrhage
- 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
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 90mgTicagrelor 90 mg plus aspirin for 12 months | Drug | Ticagrelor(90mg) |
| Ticagrelor 90mg/60mg1 month after treatment with ticagrelor 90 mg plus aspirin, followed by treatment with ticagrelor 60 mg plus aspirin for 11 months | Drug | Ticagrelor(90/60mg) |
| Clopidogrel 75mgClopidogrel 75mg plus aspirin for 12 months | Drug | Clopidogrel(75mg) |
Primary outcome
Platelet reactivity index (PRI)
Time frame: 90 days (±14)
Platelet reactivity of ticagrelor or clopidogrel MD will be measured as PRI% using whole blood vasodilator-stimulated phosphoprotein (VASP) at 90 days after PCI.
3 secondary outcomes
Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: 1 year
The platelet aggregation ratio
Time frame: 90 days (±14)
Plasma adenosine concentration
Time frame: 90 days (±14)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 90mg, Ticagrelor 90mg/60mg and Clopidogrel 75mg in people with Antiplatelet Therapy and Coronary Artery Disease, run by Beijing Anzhen 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 17 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 19 Aug 2019. 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 Yi Zhang, PhD (86-010-64456609, phd-zhangyi@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet reactivity index (PRI) (time frame: 90 days (±14)). 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 19 Aug 2019.