Drug Effect DisorderNCT02198053
the Effect Between Platelet Reactivation and Antiplatelet Drugs
An observational study of Drug Effect Disorder and Platelet Procoagulant Activity Deficiency, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Different antiplatelet drugs played various role in coronary artery disease. The mechanisms were unclear. Platelet reactivation maybe was one of major causes. Compared with clopidogrel, Ticagrelor is more powerful antiplatelet drug. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug Effect Disorder, Platelet Procoagulant Activity Deficiency
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Dec 2015
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chinese
Who may be able to join
- coronary artery disease, percutaneous coronary intervention
Who cannot join
- high risk bleeding patient, allergic to the drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 180 mgTicagrelor Compared With 90 mg Ticagrelor on Platelet Reactivity in Patients Undergoing Elective PCI.
Different antiplatelet drugs played various role in coronary artery disease. The mechanisms were unclear. Platelet reactivation maybe was one of major causes. Compared with clopidogrel, Ticagrelor is more powerful antiplatelet drug. However, because of increased bleeding and dyspnea risk, both loading double dose and following second dose time had potential risk and inconvenient in routine clinical work, especially in elective PCI of comparable stable patients in Chinese. The benefit and risk should be balanced in such patients. The investigators supposed loading single dose and followed by second routine time dose was superior to clopidogrel and safer than ticagrelor previously prescribed.
Read the detailed description
All admission patients were divided into two groups, the first group were prescribed loading dose (180 mg) ticagrelor, the second group were prescribed with 90 mg ticagrelor. We measured both platelet activity and platelet reactivity using the LTA at baseline, pre-operation and post-operation. All bleeding or dyspnea events were recorded in hospital period.
Primary endpoints: platelet activity, platelet reactivity using the LTA and safety events were recorded in hospital period.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor2 | Ticagrelor with a loading dose of 180mg followed by 90 mg twice per day | |
| Ticagrelor1 | Ticagrelor with a dose of 90mg followed by 90 mg twice per day . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity
LTA and TEG used to measure the effect of Platelet reactivity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Effect DisorderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 74 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, quan li, Beijing Anzhen Hospital
- Investigators
- LI QUAN, doctor, Study director, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198053
- Sponsor's protocol ID
- azliquan
- Status last verified
- Jul 2015
- First submitted
- 21 Jul 2014
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 180 mgTicagrelor Compared With 90 mg Ticagrelor on Platelet Reactivity in Patients Undergoing Elective PCI.
- ClinicalTrials.gov ID
- NCT02198053
- Acronym / sponsor ID
- azliquan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Jul 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.
Different antiplatelet drugs played various role in coronary artery disease. The mechanisms were unclear. Platelet reactivation maybe was one of major causes. Compared with clopidogrel, Ticagrelor is more powerful antiplatelet drug. However, because of increased bleeding and dyspnea risk, both loading double dose and following second dose time had potential risk and inconvenient in routine clinical work, especially in elective PCI of comparable stable patients in Chinese. The benefit and risk should be balanced in such patients. The investigators supposed loading single dose and followed by second routine time dose was superior to clopidogrel and safer than ticagrelor previously prescribed.
Detailed description
All admission patients were divided into two groups, the first group were prescribed loading dose (180 mg) ticagrelor, the second group were prescribed with 90 mg ticagrelor. We measured both platelet activity and platelet reactivity using the LTA at baseline, pre-operation and post-operation. All bleeding or dyspnea events were recorded in hospital period.
Primary endpoints: platelet activity, platelet reactivity using the LTA and safety events were recorded in hospital period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor2 | – | –Ticagrelor with a loading dose of 180mg followed by 90 mg twice per day |
| Ticagrelor1 | – | –Ticagrelor with a dose of 90mg followed by 90 mg twice per day . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (1 listed)
- coronary artery disease, percutaneous coronary intervention
Key exclusion criteria (1 listed)
- high risk bleeding patient, allergic to the drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Platelet reactivity
Time frame: 1 year
LTA and TEG used to measure the effect of Platelet reactivity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
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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.
LI QUAN, doctor study director
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Effect Disorder and Platelet Procoagulant Activity Deficiency, 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 1 inclusion and 1 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 22 Jul 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.
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?
Platelet reactivity (time frame: 1 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 22 Jul 2015; AzTrials last refreshed its copy on 6 Nov 2026.