Non-ST Elevation Acute Coronary SyndromePhase 4NSTE-ACSNCT02052635
Ticagrelor vs Clopidogrel in Non-ST Elevation Acute Coronary Syndrome Patients Undergoing PCI With Bivalirudin.
A Phase 4 study testing ticagrelor and clopidogrel in people with Non-ST Elevation Acute Coronary Syndrome, run by AstraZeneca at 8 sites in United States.
Trial summary
The purpose of this study is to determine if ticagrelor is as effective as clopidogrel in rate of onset and degree of platelet inhibition for patients with non-ST elevation of acute coronary syndrome (NSTE-ACS) undergoing ad hoc percutaneous coronary intervention (PCI) with bivalirudin. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Non-ST Elevation Acute Coronary Syndrome
- What is being tested?
- ticagrelor and clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2014to Apr 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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalised for chest pain and potential acute coronary syndrome.
- Onset of the most recent cardiac ischemic symptoms must occur within 7 days before randomisation and documented by cardiac ischemic symptoms of ≥ 10 min duration at rest and at least 2 of the following: ST segment changes on electrocardiogram (ECG) indicative of ischemia, or Positive biomarker evdience of myocardial necrosis, or other risk factors such as: 60 yrs of age or older, previous myocardial infarction or coronary bypass surgery, multi-vessel coronary artery disease, diabetes mellitus, peripheral arterial disease, chronic renal disfunction.
- Females must be either surgically sterile or post-menopausal.
- Activated Clotting Time (ACT) </= 300 at the time of study treatment
Who cannot join
- Participation in another clinical study with an investigational product during the last 30 days.
- Current acute complication of percutaneous coronary intervention or coronary bypass surgery.
- Any contraindication to ticagrelor, clopidogrel or bivalirudin.
- ST elevation myocardial infraction within 24 hours of study entry.
- Any indications for oral anticoagulation or aspirin dose other than 75 to 100 milligrams (mg) daily.
- Planned use of omeprazole or esomeprazole.
Show all 10Show fewer
- Patients with known bleeding or coagulation disorders; patients requiring dialysis; patients who have an inability to swallow medication.
- Patients with known bleeding diathesis or coagulation disorder; history of intracranial bleed.
- Use of Intravenous (IV) heparin less than 2 hours before procedure.
- Sustained uncontrolled high blood pressure
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Research Site
Hershey, Pennsylvania
Research Site
Jacksonville, Florida
Research Site
Lake Mary, Florida
Research Site
Macon, Georgia
Research Site
Oklahoma City, Oklahoma
Research Site
Philadelphia, Pennsylvania
Research Site
Pittsburgh, Pennsylvania
Research Site
Rapid City, South Dakota
About this study
Official title: A Phase IV, Randomised, Multi-Centre, Open Label Study, Comparing Ticagrelor Versus Clopidogrel in Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Patients Undergoing Percutaneous Coronary Intervention (PCI) With Bivalirudin
The purpose of this study is to determine if ticagrelor is as effective as clopidogrel in rate of onset and degree of platelet inhibition for patients with non-ST elevation of acute coronary syndrome (NSTE-ACS) undergoing ad hoc percutaneous coronary intervention (PCI) with bivalirudin.
Read the detailed description
Multi-center, open-label study that will compare the onset of the platelet inhibition with ticagrelor versus clopidogrel when administered with bivalirudin during PCI on a background therapy of aspirin in patients with NSTE-ACS.
- Conditions
- Non-ST Elevation Acute Coronary Syndrome
- Being tested
- ticagrelor, clopidogrel
- Keywords
- Percutaneous Coronary Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelorDrug
Also called Brilinta
Single loading dose of 180mg of ticagrelor at time of bivalirudin administration. Beginning 12 hrs following study drug administration, all pts in the ticagrelor arm will receive ticagrelor 90 mg (maintenance dose) approximately every 12 hrs until Follow-up telephone contact.
clopidogrelDrug
Also called Plavix
Single loading oral dose of 600 mg of clopidogrel will be given at time of bivalirudin administration. Beginning 4 hrs following study drug administration, all pts in the clopidorgrel arm will receive ticagrelor 180 mg for the loading dose, followed by 90 mg maintenance dose approximately every 12 hours until the Follow-up telephone contact.
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | 90 mg oral tablet Receives: Drug: ticagrelor |
| Clopidogrel | Active comparator | 300 mg oral tablet Receives: Drug: clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose
PRU at 0.5 hours after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus
Measured: 0.5 hours post loading dose
P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose
PRU at 1 hour after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus
Measured: 1 hour post loading dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Patient recruitment challenges, low enrolment, and a forecasted inability to complete the study in an acceptable timeframe
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 Elevation Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Cohen, MD, Principal investigator, Newark Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052635
- Sponsor's protocol ID
- D5130L00065
- Acronym
- NSTE-ACS
- Status last verified
- Apr 2016
- First submitted
- 14 Jan 2014
- Last updated
- 27 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomised, Multi-Centre, Open Label Study, Comparing Ticagrelor Versus Clopidogrel in Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Patients Undergoing Percutaneous Coronary Intervention (PCI) With Bivalirudin
- ClinicalTrials.gov ID
- NCT02052635
- Acronym / sponsor ID
- NSTE-ACS / D5130L00065
- Conditions
- Non-ST Elevation Acute Coronary Syndrome
- Keywords
- Percutaneous Coronary Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient recruitment challenges, low enrolment, and a forecasted inability to complete the study in an acceptable timeframe
- Enrolment
- 34 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Posted 6 Apr 2016
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 if ticagrelor is as effective as clopidogrel in rate of onset and degree of platelet inhibition for patients with non-ST elevation of acute coronary syndrome (NSTE-ACS) undergoing ad hoc percutaneous coronary intervention (PCI) with bivalirudin.
Detailed description
Multi-center, open-label study that will compare the onset of the platelet inhibition with ticagrelor versus clopidogrel when administered with bivalirudin during PCI on a background therapy of aspirin in patients with NSTE-ACS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: ticagrelor90 mg oral tablet |
| Clopidogrel | Active comparator | Drug: clopidogrel300 mg oral tablet |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalised for chest pain and potential acute coronary syndrome.
- Onset of the most recent cardiac ischemic symptoms must occur within 7 days before randomisation and documented by cardiac ischemic symptoms of ≥ 10 min duration at rest and at least 2 of the following: ST segment changes on electrocardiogram (ECG) indicative of ischemia, or Positive biomarker evdience of myocardial necrosis, or other risk factors such as: 60 yrs of age or older, previous myocardial infarction or coronary bypass surgery, multi-vessel coronary artery disease, diabetes mellitus, peripheral arterial disease, chronic renal disfunction.
- Females must be either surgically sterile or post-menopausal.
- Activated Clotting Time (ACT) </= 300 at the time of study treatment
Key exclusion criteria (10 listed)
- Participation in another clinical study with an investigational product during the last 30 days.
- Current acute complication of percutaneous coronary intervention or coronary bypass surgery.
- Any contraindication to ticagrelor, clopidogrel or bivalirudin.
- ST elevation myocardial infraction within 24 hours of study entry.
- Any indications for oral anticoagulation or aspirin dose other than 75 to 100 milligrams (mg) daily.
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: BrilintaSingle loading dose of 180mg of ticagrelor at time of bivalirudin administration. Beginning 12 hrs following study drug administration, all pts in the ticagrelor arm will receive ticagrelor 90 mg (maintenance dose) approximately every 12 hrs until Follow-up telephone contact. | Drug | Ticagrelor |
| clopidogrelAlso: PlavixSingle loading oral dose of 600 mg of clopidogrel will be given at time of bivalirudin administration. Beginning 4 hrs following study drug administration, all pts in the clopidorgrel arm will receive ticagrelor 180 mg for the loading dose, followed by 90 mg maintenance dose approximately every 12 hours until the Follow-up telephone contact. | Drug | Clopidogrel |
Primary outcome
P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose
Time frame: 0.5 hours post loading dose
PRU at 0.5 hours after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus
P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose
Time frame: 1 hour post loading dose
PRU at 1 hour after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Non-ST Elevation Acute Coronary Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 4
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
RecruitingObservational study
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome
Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT)
Active, not recruiting
Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
Acute Chest Pain, NSTEMI - Non-ST Segment Elevation MI
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.
Marc Cohen, MD principal investigator
Newark Beth Israel Medical Center
8 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 and clopidogrel in people with Non-ST Elevation Acute Coronary Syndrome, run by AstraZeneca at 8 sites in United States.
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 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: stopped early, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 6 Apr 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?
P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose (time frame: 0.5 hours post loading dose). The study lists 2 primary outcomes in all. 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 27 May 2016.