Acute Coronary SyndromePRACTICENCT03525145
Platelet Reactivity And Clinical ThrombotIC Events Study
An observational study of Acute Coronary Syndrome and Antiplatelet Therapy, run by Shenyang Northern Hospital at 1 site in China.
Trial summary
Platelet function testing has been considered for DAPT strategy adjustments to reduce the patient's risk of ischemia and bleeding. Although several previous RCT studies did not find any benefit in the detection of platelet function， the previous studies were mostly low-risk populations, and the P2Y12 receptor… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome, Antiplatelet Therapy, Platelet Reactivity
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 31 May 2020
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with acute coronary syndrome undergoing antiplatelet therapy
Who may be able to join
- Age 18-80 years old;
- There was a history of at least one acute coronary syndrome (ACS) attack within 14 days before enrollment, including unstable angina, non-ST elevation myocardial infarction, or ST-elevation myocardial infarction;
- Being treated with aspirin and a P2Y12 inhibitor (clopidogrel or ticagrelor);
- Plan to apply dual antiplatelet drugs (DAPT, aspirin + P2Y12 inhibitor) for at least 12 months;
- Voluntary signature of informed consent
Who cannot join
- In combination with other anti-platelet drugs, such as cilostazol;
- Have received glycoprotein IIb/IIIa inhibitor within 72 hours before enrollment;
- receving a P2Y12 inhibitor loading does less than 72h or maintenance (unloaded) less than 5d;
- Plan to perform any coronary revascularization within 30 days;
- The need for oral anticoagulants (warfarin, factor II or factor X inhibitors);
- Predicted survival time <12 months for patients with known severe progressive disease (such as malignancy) or extreme depletion of the disease;
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- pregnant women or pregnant people;
- Any situation that may interfere with the research process, such as dementia, delirium, alcoholism, etc.;
- expected to undergo surgery within 1 year;
- Patients participating in other ongoing clinical studies
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Northern Hospital
Shenyang, Liaoning
Yaling Han, Dr, +86-24-23922184, 13998847715@qq.com
Yaling Han, MD
About this study
Platelet function testing has been considered for DAPT strategy adjustments to reduce the patient's risk of ischemia and bleeding. Although several previous RCT studies did not find any benefit in the detection of platelet function， the previous studies were mostly low-risk populations, and the P2Y12 receptor antagonists were simply clopidogrel, and the detection methods were relatively simple. Therefore, the need for platelet monitoring in high-risk ACS patients receiving new potent P2Y12 inhibitor ticagrelor, as well as the diagnostic threshold for different platelet function assays needs further study. In addition, due to the differences on the response to anti-platelet drugs between the East and the West, it is not appropriate to simply refer to the conclusion of the other party. However, as of now, there is no large sample randomized controlled study systematically focused on the applicability and status of platelet function tests in East Asian populations, especially Chinese populations.
- Keywords
- Platelet Reactivity, Thrombotic Events
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular thrombotic events
Cardiovascular death, non-fatal myocardial infarction, stroke, or stent thrombosis
Measured: One Year
Secondary outcomes (3)
Cardiovascular death
Cardiovascular death
Measured: One Year
BARC(Bleeding Academic Research Consortium )2-5 Bleeding
BARC2-5 Bleeding
Measured: One Year
MACCE(Major adverse cardiac and cerebral events)
Cardiovascular death, non-fatal myocardial infarction, stroke, or ischemic-driven target vessel revascularization
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 posted15 May 2018
- Study start1 Sep 2018
- Primary completion31 May 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 1 Year
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, Study director, Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525145
- Sponsor's protocol ID
- PRACTICEV1.02
- Acronym
- PRACTICE
- Status last verified
- Jan 2019
- First submitted
- 25 Apr 2018
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Reactivity And Clinical ThrombotIC Events Study
- ClinicalTrials.gov ID
- NCT03525145
- Acronym / sponsor ID
- PRACTICE / PRACTICEV1.02
- Keywords
- Platelet Reactivity, Thrombotic Events
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 15 May 2018 (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.
Platelet function testing has been considered for DAPT strategy adjustments to reduce the patient's risk of ischemia and bleeding. Although several previous RCT studies did not find any benefit in the detection of platelet function， the previous studies were mostly low-risk populations, and the P2Y12 receptor antagonists were simply clopidogrel, and the detection methods were relatively simple. Therefore, the need for platelet monitoring in high-risk ACS patients receiving new potent P2Y12 inhibitor ticagrelor, as well as the diagnostic threshold for different platelet function assays needs further study. In addition, due to the differences on the response to anti-platelet drugs between the East and the West, it is not appropriate to simply refer to the conclusion of the other party. However, as of now, there is no large sample randomized controlled study systematically focused on the applicability and status of platelet function tests in East Asian populations, especially Chinese populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with acute coronary syndrome undergoing antiplatelet therapy
Key inclusion criteria (5 listed)
- Age 18-80 years old;
- There was a history of at least one acute coronary syndrome (ACS) attack within 14 days before enrollment, including unstable angina, non-ST elevation myocardial infarction, or ST-elevation myocardial infarction;
- Being treated with aspirin and a P2Y12 inhibitor (clopidogrel or ticagrelor);
- Plan to apply dual antiplatelet drugs (DAPT, aspirin + P2Y12 inhibitor) for at least 12 months;
- Voluntary signature of informed consent
Key exclusion criteria (10 listed)
- In combination with other anti-platelet drugs, such as cilostazol;
- Have received glycoprotein IIb/IIIa inhibitor within 72 hours before enrollment;
- receving a P2Y12 inhibitor loading does less than 72h or maintenance (unloaded) less than 5d;
- Plan to perform any coronary revascularization within 30 days;
- The need for oral anticoagulants (warfarin, factor II or factor X inhibitors);
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
Cardiovascular thrombotic events
Time frame: One Year
Cardiovascular death, non-fatal myocardial infarction, stroke, or stent thrombosis
3 secondary outcomes
Cardiovascular death
Time frame: One Year
BARC(Bleeding Academic Research Consortium )2-5 Bleeding
Time frame: One Year
MACCE(Major adverse cardiac and cerebral 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 4 Jan 2019.
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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 study director
Northern 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 Acute Coronary Syndrome and Antiplatelet Therapy, 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 10 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 4 Jan 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.
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 Li, MD (86-13309886850, doctorliyi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular thrombotic events (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 4 Jan 2019; AzTrials last refreshed its copy on 4 Nov 2026.