Coronary Heart DiseasePhase 4NCT02219412
Arachidonic Acid-induced Platelet Aggregation Rate in Patients With Stable CAD Treated With Ticagrelor Monotherapy
A Phase 4 study testing ticagrelor and Aspirin in people with Coronary Heart Disease, run by Yong Huo at 1 site in China.
Trial summary
This study was a feasibility trial that was designed to provide preliminary observations and generate hypotheses for future studies. The aim of the study is to estimate the difference of arachidonic acid induced platelet aggregation rate between ticagrelor mono-therapy and aspirin/ticagrelor dual-therapy after 14 days… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- ticagrelor and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Aug 2015
- 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
- Provision of informed consent prior to any study specific procedures.
- Aged >18 years.
- Documented stable coronary artery disease.
- Currently receiving dual-antiplatelet therapy with aspirin 100mg/d and clopidogrel 75mg/d.
Who cannot join
- History of acute coronary syndrome within 12 months of screening.
- History of percutaneous coronary intervention within 12 months of screening.
- Any indication (eg, atrial fibrillation,prosthetic heart valve, or coronary stent) for antithrombotic therapy(eg, warfarin, clopidogrel, or aspirin dose other than 75 to 100 mg/during the study period).
- AA induced platelet aggregation rate >20% on aspirin+clopidogrel measured by light transmission platelet aggregation test with the past 3 months.
- Congestive heart failure or left ventricular ejection fraction <35%.
- Forced expiratory volume in the first second forced vital capacity below the lower limits of normal.
Show all 19Show fewer
- Bleeding diathesis or severe pulmonary disease.
- Active pathological bleeding.
- History of intracranial hemorrhage.
- Hypersensitivity to ticagrelor or any of the excipients.
- Severe hepatic impairment.
- Pregnancy.
- Current smoking.
- Platelet count <100 000/mm3 or hemoglobin <10 g/dL.
- HemoglobinA1c >10%.
- History of drug addiction or alcohol abuse in the past 2 years.
- Need for nonsteroidal anti-inflammatory drug.
- Creatinine clearance<30 mL/min.
- Concomitant therapy with moderate or strong cytochrome P450 3A inhibitors, substrates, or strong cytochrome P450 3A inducers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Two Arms, Randomized Controlled Pilot Study Comparing the Arachidonic Acid-induced Platelet Aggregation Rate in Patients With Stable Coronary Artery Disease Treated With Ticagrelor Monotherapy or Ticagrelor and Asprin
This study was a feasibility trial that was designed to provide preliminary observations and generate hypotheses for future studies. The aim of the study is to estimate the difference of arachidonic acid induced platelet aggregation rate between ticagrelor mono-therapy and aspirin/ticagrelor dual-therapy after 14 days of treatment in patients with stable coronary artery disease. The potential hypothesis is that the arachidonic acid (AA) induced platelet aggregation rate after 2 weeks of ticagrelor mono-therapy is comparable to that of aspirin/ticagrelor dual-therapy.
Read the detailed description
This is a randomized, open labeled, active-controlled pilot study to estimate the difference of arachidonic acid induced platelet aggregation rate between ticagrelor monotherapy and aspirin/ticagrelor dual-therapy in patients with stable coronary heart disease. The anticipated duration of the study is approximately 9 months, including an anticipated enrolment period of 8 months and follow-up period of 4weeks.
Patients with documented coronary heart disease and currently receiving dual-antiplatelet therapy with standard dose aspirin and clopidogrel will be enrolled from the study site. For patients post acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI), they must be on dual-antiplatelet therapy for at least 12 months to be eligible for the study.
The study plan, including enrolment/randomization and follow-up visits, is outlined in Table 1. Eligible patients will enter a washout phase with ticagrelor for 2 weeks. Then they will be randomized to take either ticagrelor alone or aspirin/ticagrelor for 14 days. The efficacy evaluation will be done at 7 and 14days after randomization. The primary efficacy parameter is the rate of arachidonic acid induced platelet aggregation after 14 days of treatment. All patients will be treated to standards of care for coronary heart disease secondary prevention.
Visit 0 (Screening and Enrollment, 0 day) All potentially eligible patients will undergo a screening visit following their signed informed consent.
Following an 8-hour fast, the patients will have screening evaluations performed. Demography, medical history, and concomitant medication will be recorded. A physical examination and vital signs(pulse and BP), height and weight, as well as blood sampling for laboratory assessments of complete blood count (CBC) with differential, serum creatinine, alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and AA, adenosine diphosphate (ADP) and collagen induced platelet aggregation rate will be done. Standard 12-lead electrocardiogram (ECG) readings will be recorded.
Patients meeting all inclusion criteria and with no exclusion criteria will be enrolled. Patients will receive ticagrelor mono-therapy from the evening for 14 days. IP will be dispensed.
Visit 1 (Randomization, 14 days) Suspected adverse events (AEs) will be recorded. A physical examination and vital signs (pulse and BP), as well as blood sampling for laboratory assessments of AA, ADP and collagen induced platelet aggregation rate and serum thromboxane B2 concentration will be done.
Patients should be told to take ticagrelor in the morning of Visit 1. Patients will be randomized in a 1:1 ratio to receive either ticagrelor mono-therapy or aspirin/ticagrelor dual-therapy. Investigational product (IP) will be returned and compliance assessed and new bottles of IP will be dispensed according to randomized groups.
Visit 2 (21 days) Suspected AEs will be recorded. Vital signs (pulse and BP) as well as blood sampling for laboratory assessments of AA, ADP and collagen induced platelet aggregation rate will be done.
Visit 3 (End of treatment, 28 days) Suspected AEs will be recorded. Vital signs (pulse and BP) as well as blood sampling for laboratory assessments of CBC with differential, Scr, ALT and AST, AA, ADP and collagen induced platelet aggregation rate will be done. IP will be returned and compliance assessed. Instructions for medication after study will be given to patients at this time.
For patients who prematurely discontinued the randomized treatment, a complete end of treatment visit will be preferred.
- Conditions
- Coronary Heart Disease
- Being tested
- ticagrelor, Aspirin
- Keywords
- ticagrelor, platelet aggregation rate, ADP antagonist, antiplatelet therapy
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelorDrug
Also called Brilinta
90 mg bid for 2 weeks
AspirinDrug
100mg Qd for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ticagrelor mono-therapy | Experimental | Take ticagrelor 90 mg Bid for 2 weeks. Receives: Drug: ticagrelor |
| aspirin/ticagrelor dual-therapy | Active comparator | Take ticagrelor 90mg Bid plus Aspirin 100mg Qd and treated for 2 weeks. Receives: Drug: ticagrelor; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of AA induced platelet aggregation
The rate of AA induced platelet aggregation will be measured at day 14 after randomization.
Measured: Day 14 after randomization
Secondary outcomes (4)
The rate of ADP induced platelet aggregation
The rate of ADP induced platelet aggregation will be measured at day 7 and day 14 after randomization.
Measured: Day 7 and day 14 after randomization
The rate of collagen induced platelet aggregation
The rate of d collagen induced platelet aggregation will be measured at day 7 and day 14 after randomization.
Measured: Day 7 and day 14 after randomization
The serum concentration of Thromboxane B2
The serum concentration of Thromboxane B2 will be measured at day7 and day 14 after randomization
Measured: Day 7 and day 14 after randomization
The rate of AA induced platelet aggregation
The rate of collagen induced platelet aggregation will be measured on Day 7 after randomization
Measured: Day 7 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yong Huo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yong Huo, Peking University First Hospital
- Investigators
- Huo Yong, MD, Study chair, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219412
- Sponsor's protocol ID
- ISSBRIL0235
- Status last verified
- Jun 2016
- First submitted
- 24 Jul 2014
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Two Arms, Randomized Controlled Pilot Study Comparing the Arachidonic Acid-induced Platelet Aggregation Rate in Patients With Stable Coronary Artery Disease Treated With Ticagrelor Monotherapy or Ticagrelor and Asprin
- ClinicalTrials.gov ID
- NCT02219412
- Acronym / sponsor ID
- ISSBRIL0235
- Conditions
- Coronary Heart Disease
- Keywords
- ticagrelor, platelet aggregation rate, ADP antagonist, antiplatelet therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Yong HuoUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Aug 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.
This study was a feasibility trial that was designed to provide preliminary observations and generate hypotheses for future studies. The aim of the study is to estimate the difference of arachidonic acid induced platelet aggregation rate between ticagrelor mono-therapy and aspirin/ticagrelor dual-therapy after 14 days of treatment in patients with stable coronary artery disease. The potential hypothesis is that the arachidonic acid (AA) induced platelet aggregation rate after 2 weeks of ticagrelor mono-therapy is comparable to that of aspirin/ticagrelor dual-therapy.
Detailed description
This is a randomized, open labeled, active-controlled pilot study to estimate the difference of arachidonic acid induced platelet aggregation rate between ticagrelor monotherapy and aspirin/ticagrelor dual-therapy in patients with stable coronary heart disease. The anticipated duration of the study is approximately 9 months, including an anticipated enrolment period of 8 months and follow-up period of 4weeks.
Patients with documented coronary heart disease and currently receiving dual-antiplatelet therapy with standard dose aspirin and clopidogrel will be enrolled from the study site. For patients post acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI), they must be on dual-antiplatelet therapy for at least 12 months to be eligible for the study.
The study plan, including enrolment/randomization and follow-up visits, is outlined in Table 1. Eligible patients will enter a washout phase with ticagrelor for 2 weeks. Then they will be randomized to take either ticagrelor alone or aspirin/ticagrelor for 14 days. The efficacy evaluation will be done at 7 and 14days after randomization. The primary efficacy parameter is the rate of arachidonic acid induced platelet aggregation after 14 days of treatment. All patients will be treated to standards of care for coronary heart disease secondary prevention.
Visit 0 (Screening and Enrollment, 0 day) All potentially eligible patients will undergo a screening visit following their signed informed consent.
Following an 8-hour fast, the patients will have screening evaluations performed. Demography, medical history, and concomitant medication will be recorded. A physical examination and vital signs(pulse and BP), height and weight, as well as blood sampling for laboratory assessments of complete blood count (CBC) with differential, serum creatinine, alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and AA, adenosine diphosphate (ADP) and collagen induced platelet aggregation rate will be done. Standard 12-lead electrocardiogram (ECG) readings will be recorded.
Patients meeting all inclusion criteria and with no exclusion criteria will be enrolled. Patients will receive ticagrelor mono-therapy from the evening for 14 days. IP will be dispensed.
Visit 1 (Randomization, 14 days) Suspected adverse events (AEs) will be recorded. A physical examination and vital signs (pulse and BP), as well as blood sampling for laboratory assessments of AA, ADP and collagen induced platelet aggregation rate and serum thromboxane B2 concentration will be done.
Patients should be told to take ticagrelor in the morning of Visit 1. Patients will be randomized in a 1:1 ratio to receive either ticagrelor mono-therapy or aspirin/ticagrelor dual-therapy. Investigational product (IP) will be returned and compliance assessed and new bottles of IP will be dispensed according to randomized groups.
Visit 2 (21 days) Suspected AEs will be recorded. Vital signs (pulse and BP) as well as blood sampling for laboratory assessments of AA, ADP and collagen induced platelet aggregation rate will be done.
Visit 3 (End of treatment, 28 days) Suspected AEs will be recorded. Vital signs (pulse and BP) as well as blood sampling for laboratory assessments of CBC with differential, Scr, ALT and AST, AA, ADP and collagen induced platelet aggregation rate will be done. IP will be returned and compliance assessed. Instructions for medication after study will be given to patients at this time.
For patients who prematurely discontinued the randomized treatment, a complete end of treatment visit will be preferred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ticagrelor mono-therapy | Experimental | Drug: ticagrelorTake ticagrelor 90 mg Bid for 2 weeks. |
| aspirin/ticagrelor dual-therapy | Active comparator | Drug: ticagrelor, Drug: AspirinTake ticagrelor 90mg Bid plus Aspirin 100mg Qd and treated for 2 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of informed consent prior to any study specific procedures.
- Aged >18 years.
- Documented stable coronary artery disease.
- Currently receiving dual-antiplatelet therapy with aspirin 100mg/d and clopidogrel 75mg/d.
Key exclusion criteria (19 listed)
- History of acute coronary syndrome within 12 months of screening.
- History of percutaneous coronary intervention within 12 months of screening.
- Any indication (eg, atrial fibrillation,prosthetic heart valve, or coronary stent) for antithrombotic therapy(eg, warfarin, clopidogrel, or aspirin dose other than 75 to 100 mg/during the study period).
- AA induced platelet aggregation rate >20% on aspirin+clopidogrel measured by light transmission platelet aggregation test with the past 3 months.
- Congestive heart failure or left ventricular ejection fraction <35%.
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: Brilinta90 mg bid for 2 weeks | Drug | aspirin/ticagrelor dual-therapy, ticagrelor mono-therapy |
| Aspirin100mg Qd for 2 weeks. | Drug | aspirin/ticagrelor dual-therapy |
Primary outcome
The rate of AA induced platelet aggregation
Time frame: Day 14 after randomization
The rate of AA induced platelet aggregation will be measured at day 14 after randomization.
4 secondary outcomes
The rate of ADP induced platelet aggregation
Time frame: Day 7 and day 14 after randomization
The rate of collagen induced platelet aggregation
Time frame: Day 7 and day 14 after randomization
The serum concentration of Thromboxane B2
Time frame: Day 7 and day 14 after randomization
The rate of AA induced platelet aggregation
Time frame: Day 7 after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Huo Yong, MD study chair
Peking University First Hospital
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 and Aspirin in people with Coronary Heart Disease, run by Yong Huo 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 4 inclusion and 19 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 21 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The rate of AA induced platelet aggregation (time frame: Day 14 after randomization). 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 21 Jun 2016.