LOVASTATIN/TICAGRELOR [VA Drug Interaction]Phase 4NCT02658838
The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI
A Phase 4 study testing Ticagrelor, full amount low molecular weight heparin and half amount low molecular weight heparin in people with LOVASTATIN/TICAGRELOR [VA Drug Interaction], run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine ticagrelor combining with low molecular weight heparin is effective and safe during PCI or not. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- LOVASTATIN/TICAGRELOR [VA Drug Interaction]
- What is being tested?
- Ticagrelor, full amount low molecular weight heparin and half amount low molecular weight heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Sep 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old and ≤75 years ;
- unstable angina, non-ST segment elevation acute myocardial infarction, old myocardial infarction, or confirm the presence of myocardial ischemia;
- voluntary participation in clinical trials, and informed consent;
Who cannot join
- acute ST segment elevation myocardial infarction, stable angina pectoris;
- aspirin allergy or resistance;
- consolidated stroke, chronic obstructive pulmonary disease and other ticagrelor contraindications;
- patients have coagulopathy;
- can not be continued for one year with aspirin and treatment of dual antiplatelet ticagrelor;
- can not complete revascularization;
- NYHA ≥Ⅲ level or left ventricular ejection fraction <40%;
- severe liver and kidney dysfunction (ALT and AST were more than three times the upper limit of normal, creatinine clearance less than 30ml / min-1.1.72m-2);
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine ticagrelor combining with low molecular weight heparin is effective and safe during PCI or not.
Read the detailed description
Ticagrelor is a new drug compared with clopidogrel. It has a stronger antiplatelet capacity. After PCI，whether using low molecular weight heparin can make patients better prognosis or not, What's more，full amount or half amount low molecular weight heparin?, also investigators want to explore that whether it may lead to more bleeding events.
- Being tested
- Ticagrelor, full amount low molecular weight heparin, half amount low molecular weight heparin, No low molecular weight heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Antiplatelet drugs
Patients were treated with full amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.
full amount low molecular weight heparinDrug
Also called Full amount enoxaparin
Patients were treated with half amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.
half amount low molecular weight heparinDrug
Also called Half amount enoxaparin
Patients were treated with half amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.
No low molecular weight heparinDrug
Also called No enoxaparin
Patients were treated with no low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.
| Study group | Role | What they receive |
|---|---|---|
| full amount low molecular weight heparin | Experimental | Patients were treated with ticagrelor one year，After PCI， the patients are treated with full amount low molecular weight heparin until they leave hospital. Receives: Drug: Ticagrelor; Drug: full amount low molecular weight heparin |
| half amount low molecular weight heparin | Experimental | Patients were treated with ticagrelor one year，After PCI， the patients are treated with half amount low molecular weight heparin until they leave hospital. Receives: Drug: Ticagrelor; Drug: half amount low molecular weight heparin |
| No low molecular weight heparin | Experimental | Patients were treated with ticagrelor one year，After PCI， the patients are treated with no low molecular weight heparin. Receives: Drug: Ticagrelor; Drug: No low molecular weight heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: one year
Secondary outcomes (5)
Nonfatal myocardial infarction
Patients occur acute myocardial infarction in a year，but it could not lead to die.
Measured: one year
Non-fatal stroke
Patients occur stroke in a year，but it could not lead to die.
Measured: one year
Revascularization again
Coronary arteries occur stenosis again in a year，the patients are treated with revascularization，including PCI and CABG.
Measured: one year
Rehospitalization for ACS or heart failure
Patients are hospitalized again because of ACS or heart failure in a year.
Measured: one year
Bleeding events
assessing the bleeding events according the TIMI grade.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startApr 2015
- Primary completionAug 2016 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LOVASTATIN/TICAGRELOR [VA Drug Interaction]Studies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Jing Ye, Beijing Anzhen Hospital
- Investigators
- jinghua Liu, Study director, Beijing Anzhen hosipital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658838
- Sponsor's protocol ID
- TLPCI
- Status last verified
- Aug 2015
- First submitted
- 13 Jan 2016
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI
- ClinicalTrials.gov ID
- NCT02658838
- Acronym / sponsor ID
- TLPCI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 20 Jan 2016 (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 determine ticagrelor combining with low molecular weight heparin is effective and safe during PCI or not.
Detailed description
Ticagrelor is a new drug compared with clopidogrel. It has a stronger antiplatelet capacity. After PCI，whether using low molecular weight heparin can make patients better prognosis or not, What's more，full amount or half amount low molecular weight heparin?, also investigators want to explore that whether it may lead to more bleeding events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| full amount low molecular weight heparin | Experimental | Drug: Ticagrelor, Drug: full amount low molecular weight heparinPatients were treated with ticagrelor one year，After PCI， the patients are treated with full amount low molecular weight heparin until they leave hospital. |
| half amount low molecular weight heparin | Experimental | Drug: Ticagrelor, Drug: half amount low molecular weight heparinPatients were treated with ticagrelor one year，After PCI， the patients are treated with half amount low molecular weight heparin until they leave hospital. |
| No low molecular weight heparin | Experimental | Drug: Ticagrelor, Drug: No low molecular weight heparinPatients were treated with ticagrelor one year，After PCI， the patients are treated with no low molecular weight heparin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years old and ≤75 years ;
- unstable angina, non-ST segment elevation acute myocardial infarction, old myocardial infarction, or confirm the presence of myocardial ischemia;
- voluntary participation in clinical trials, and informed consent;
Key exclusion criteria (8 listed)
- acute ST segment elevation myocardial infarction, stable angina pectoris;
- aspirin allergy or resistance;
- consolidated stroke, chronic obstructive pulmonary disease and other ticagrelor contraindications;
- patients have coagulopathy;
- can not be continued for one year with aspirin and treatment of dual antiplatelet ticagrelor;
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: Antiplatelet drugsPatients were treated with full amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year. | Drug | No low molecular weight heparin, full amount low molecular weight heparin, half amount low molecular weight heparin |
| full amount low molecular weight heparinAlso: Full amount enoxaparinPatients were treated with half amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year. | Drug | full amount low molecular weight heparin |
| half amount low molecular weight heparinAlso: Half amount enoxaparinPatients were treated with half amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year. | Drug | half amount low molecular weight heparin |
| No low molecular weight heparinAlso: No enoxaparinPatients were treated with no low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year. | Drug | No low molecular weight heparin |
Primary outcome
all cause mortality
Time frame: one year
5 secondary outcomes
Nonfatal myocardial infarction
Time frame: one year
Non-fatal stroke
Time frame: one year
Revascularization again
Time frame: one year
Rehospitalization for ACS or heart failure
Time frame: one year
Bleeding events
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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.
jinghua Liu study director
Beijing Anzhen hosipital
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, full amount low molecular weight heparin and half amount low molecular weight heparin in people with LOVASTATIN/TICAGRELOR [VA Drug Interaction], 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 3 inclusion and 8 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 20 Jan 2016. 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?
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?
all cause mortality (time frame: one year). 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 20 Jan 2016.