Non ST Segment Elevation Acute Coronary SyndromePhase 4NCT01962428
Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI
A Phase 4 study testing ticagrelor in people with Non ST Segment Elevation Acute Coronary Syndrome, run by General Hospital of Chinese Armed Police Forces at 2 sites in China.
Trial summary
It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus conventional loading dose(180mg) will result in a higher inhibition of platelet aggregation(IPA) without increasing the bleeding events. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non ST Segment Elevation Acute Coronary Syndrome
- What is being tested?
- ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures.
- Male or non-pregnant female; aged from 18 to 80 years old.
- Patients with non-ST-segment elevation acute coronary syndromes who were scheduled to undergoing PCI.
Who cannot join
- Any contraindication against the use of ticagrelor.
- On treatment with a P2Y12 receptor antagonist in past 30 days.
- Known allergies to aspirin or ticagrelor.
- On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
- Known blood dyscrasia or bleeding diathesis.
- ST-segment elevation acute myocardial infarction.
- Non-ST segment elevation acute coronary syndrome with high-risk features warranting emergency coronary angiography.
- Left ventricular ejection fraction ≤30%; renal failure with creatinine 3 mg/dl; history of liver disease; an increased risk of bradycardia, and concomitant therapy with drugs interfering with CYP3A4 metabolism.
Trial locations and contacts
2 sites in 1 country.
China2 sites
General Hospital of Chinese People's Armed Police Forces
Beijing, Beijing Municipality, 100039
General Hospital of Chinese People's Armed Police Forces
Beijing
About this study
Official title: Randomized Trial of Different Loading Dose of Ticagrelor for Antiplatelet Effect in Patients With Non -ST-segment Elevation ACS Undergoing Percutaneous Coronary Intervention
It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus conventional loading dose(180mg) will result in a higher inhibition of platelet aggregation(IPA) without increasing the bleeding events.
Read the detailed description
After providing written informed consent, all patients will be randomized to receive ticagrelor 360mg or 180mg loading dose(LD),then 90mg bid maintenance dose starting 12 hours after LD.PCI will performed in 2h-72h after they are given the loading dose.All patients should receive acetylsalicylic acid (ASA) 75 to 100 mg daily unless intolerant.IPA at 0, 0.5, 1, 2, 8, 24h after the loading dose of ticagrelor will be measured. CK-MB, troponin I, myoglobin, CRP will be detected at 0h, before PCI, 8h after PCI, 24h after PCI. ECG will be conducted at 0h and within 24h after PCI. Patients returned 28 days for follow-up visits after the loading dose of ticagrelor, documented any adverse events.
- Being tested
- ticagrelor
- Keywords
- ticagrelor, loading dose, non-ST-segment elevation acute coronary syndromes, percutaneous coronary intervention, the antiplatelet effects, bleeding events, major adverse cardiac events
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelorDrug
Also called Brilinta
Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
| Study group | Role | What they receive |
|---|---|---|
| high loading dose of ticagrelor | Experimental | Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose. Receives: Drug: ticagrelor |
| conventional loading dose of ticagrelor | Active comparator | Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose. Receives: Drug: ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Reactivity Index(PRI) Measured by VASP-P
Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI).
Measured: 2 hours after the loading dose of ticagrelor
Secondary outcomes (2)
Platelet Reactivity Index (PRI) Measured by VASP-P
Measured: 0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor
Bleeding Events
Measured: follow-up for 28 days after the loading dose of ticagrelor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non ST Segment Elevation 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Chinese Armed Police Forces
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huiliang Liu, Doctor, Principal investigator, Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962428
- Sponsor's protocol ID
- ISSBRIL0214
- Status last verified
- Dec 2015
- First submitted
- 10 Oct 2013
- Last updated
- 9 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Different Loading Dose of Ticagrelor for Antiplatelet Effect in Patients With Non -ST-segment Elevation ACS Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01962428
- Acronym / sponsor ID
- ISSBRIL0214
- Keywords
- ticagrelor, loading dose, non-ST-segment elevation acute coronary syndromes, percutaneous coronary intervention, the antiplatelet effects, bleeding events, major adverse cardiac events
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- General Hospital of Chinese Armed Police ForcesUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Posted 9 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus conventional loading dose(180mg) will result in a higher inhibition of platelet aggregation(IPA) without increasing the bleeding events.
Detailed description
After providing written informed consent, all patients will be randomized to receive ticagrelor 360mg or 180mg loading dose(LD),then 90mg bid maintenance dose starting 12 hours after LD.PCI will performed in 2h-72h after they are given the loading dose.All patients should receive acetylsalicylic acid (ASA) 75 to 100 mg daily unless intolerant.IPA at 0, 0.5, 1, 2, 8, 24h after the loading dose of ticagrelor will be measured. CK-MB, troponin I, myoglobin, CRP will be detected at 0h, before PCI, 8h after PCI, 24h after PCI. ECG will be conducted at 0h and within 24h after PCI. Patients returned 28 days for follow-up visits after the loading dose of ticagrelor, documented any adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high loading dose of ticagrelor | Experimental | Drug: ticagrelorPatients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose. |
| conventional loading dose of ticagrelor | Active comparator | Drug: ticagrelorPatients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent prior to any study specific procedures.
- Male or non-pregnant female; aged from 18 to 80 years old.
- Patients with non-ST-segment elevation acute coronary syndromes who were scheduled to undergoing PCI.
Key exclusion criteria (8 listed)
- Any contraindication against the use of ticagrelor.
- On treatment with a P2Y12 receptor antagonist in past 30 days.
- Known allergies to aspirin or ticagrelor.
- On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
- Known blood dyscrasia or bleeding diathesis.
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: BrilintaPatients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose. | Drug | conventional loading dose of ticagrelor, high loading dose of ticagrelor |
Primary outcome
Platelet Reactivity Index(PRI) Measured by VASP-P
Time frame: 2 hours after the loading dose of ticagrelor
Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI).
2 secondary outcomes
Platelet Reactivity Index (PRI) Measured by VASP-P
Time frame: 0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor
Bleeding Events
Time frame: follow-up for 28 days after the loading dose of ticagrelor
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Huiliang Liu, Doctor principal investigator
Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
2 sites 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 in people with Non ST Segment Elevation Acute Coronary Syndrome, run by General Hospital of Chinese Armed Police Forces at 2 sites 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: finished, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 9 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Index(PRI) Measured by VASP-P (time frame: 2 hours after the loading dose of ticagrelor). 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 9 Nov 2016.