Acute Coronary SyndromePhase 2NCT01919723
Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion
A Phase 2 study testing Ticagrelor and Eptifibatide in people with Acute Coronary Syndrome, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
This purpose of this study is to measure platelet response to ticagrelor and eptifibatide bolus-only compared with ticagrelor and eptifibatide bolus plus 2-hour infusion administrated after cardiac catheterization in patients undergoing non-emergent percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Ticagrelor and Eptifibatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to Dec 2015
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion in the study subjects should fulfill the following criteria:
- Provision of informed consent prior to any study specific procedures
- Males and females aged 19 years and older
- Congruent to the PLATO trial, at least two of the following three criteria have to be met:
- ST-segment changes on electrocardiography, indicating ischemia; (In electrocardiography, the ST segment connects the QRS complex and the T wave and has a duration of 0.080 to 0.120 sec (80 to 120 ms).
- a positive test of a biomarker, indicating myocardial necrosis; or one of several risk factors;
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- age >60 years
- previous myocardial infarction or Coronary-Artery Bypass Grafting [CABG];
- coronary artery disease with stenosis of ≥50% in at least two vessels;
- previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization;
- diabetes mellitus;
- peripheral arterial disease;
- or chronic renal dysfunction, defined as a creatinine clearance of <60 ml per minute per 1.73 m2 of body surface area).
- patients with symptoms of unstable angina lasting ≥10 min and either an elevated troponin I level or newly developed ST-segment depression of 1 mm or transient ST-segment elevation of 1 mm will also be included.
Who cannot join
- Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Patients with active pathological bleeding or a history of intracranial bleeding;
- patients with planned to urgent coronary artery bypass graft surgery;
- severe hepatic impairment;
- concomitant therapy with a strong cytochrome P-450 3A inhibitors, where 3A is s subfamily of the cytochrome P450 superfamily of genes;
- surgery<4 weeks;
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- the use of any thienopyridine (within the previous two weeks);
- upstream use of Glycoprotein (GP) IIb/IIIa inhibitors;
- bleeding diathesis or major bleeding episode within 2 weeks;
- a need for oral anticoagulation therapy;
- thrombocytopenia;
- presence of thrombus in the coronary artery; incessant chest pain or hemodynamic instability;
- and patients with glomerular filtration rate (GFR)<30 mL/min or on hemodialysis.
- maintenance dose of aspirin above 100mg
- history of allergies to Ticagrelor
- patients at increased risk of bradycardic events (e.g., patients who have sick sinus syndrome, 2nd or 3rd degree Atrioventricular block (AV block), or bradycardic related syncope and not protected with a pacemaker
- women who are pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama
Birmingham, Alabama, 35294
University of Cincinnati
Cincinnati, Ohio, 45267
About this study
Official title: Pharmacodynamic Effects of Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion in Patients Undergoing Percutaneous Coronary Intervention
This purpose of this study is to measure platelet response to ticagrelor and eptifibatide bolus-only compared with ticagrelor and eptifibatide bolus plus 2-hour infusion administrated after cardiac catheterization in patients undergoing non-emergent percutaneous coronary intervention.
Read the detailed description
In this study, 70 patients with Acute Coronary Syndrome who are undergoing non-emergent percutaneous coronary intervention (PCI) will be randomized to ticagrelor loading dose and eptifibatide bolus-only versus ticagrelor loading dose and eptifibatide bolus plus 2 hour infusion administrated after cardiac catheterization, but before PCI. Platelet function testing will be performed at baseline and follow-up.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Ticagrelor, Eptifibatide
- Keywords
- PCI, Ticagrelor, Eptifibatide
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brilinta
Ticagrelor loading dose
EptifibatideDrug
Also called Integrilin
i.v. infusion
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor and Eptifibatide bolus | Active comparator | Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart) Receives: Drug: Ticagrelor; Drug: Eptifibatide |
| Ticagrelor & Eptifibatide bolus+infusion | Active comparator | Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours) Receives: Drug: Ticagrelor; Drug: Eptifibatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent Inhibition of Platelet Aggregation (%IPA)
Change from baseline in %IPA at 2 hours after stimulation with 20µM ADP (µM-micromolar, ADP-Adenosine diphosphate), measured in blood by an aggregometer among patients randomized to ticagrelor and 2 boluses of eptifibatide vs. ticagrelor and 2 boluses plus infusion of eptifibatide.
Measured: Baseline and 2 hours
Secondary outcomes (3)
High On-treatment Platelet Reactivity (HPR)
Percentage of participants with HPR. HPR is defined as platelet aggregation >59% in response to 20 µM ADP.
Measured: Comparing baseline and follow-up (2 hours)
Bleeding Complications
Number of subjects that developed gastrointestinal bleeding after Percutaneous Coronary Intervention (PCI). These subjects were categorized under Bleeding Academic Research Consortium 3b. Type 3b bleeding includes overt bleeding plus a hemoglobin drop of ≥5 g/dL (provided the hemoglobin drop is related to bleeding), cardiac tamponade, bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), and bleeding requiring intravenous vasoactive drugs.
Measured: up to 24 hours
Periprocedural Myocardial Infarction (PMI)
Number of subjects that developed PMI. Periprocedural myocardial infarction (PMI) was defined as an increase in troponin I values >5 x 99th percentile the upper limit of normal in patients with normal baseline value on admission, or a rise of troponin I values >20% after PCI if the baseline value was elevated.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startFeb 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Massoud Leesar, University of Alabama at Birmingham
- Investigators
- Massoud Leesar, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919723
- Sponsor's protocol ID
- ISSBRIL0077
- Status last verified
- Jan 2017
- First submitted
- 3 Jul 2013
- Last updated
- 28 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Marian MJ, Alli O, Al Solaiman F, Brott BC, Sasse M, Leesar T, Prabhu SD, Leesar MA. Ticagrelor and Eptifibatide Bolus Versus Ticagrelor and Eptifibatide Bolus With 2-Hour Infusion in High-Risk Acute Coronary Syndromes Patients Undergoing Early Percutaneous Coronary Intervention. J Am Heart Assoc. 2017 Jun 13;6(6):e005562. doi: 10.1161/JAHA.117.005562.
PubMed 28611098
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Effects of Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion in Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01919723
- Acronym / sponsor ID
- ISSBRIL0077
- Conditions
- Acute Coronary Syndrome
- Keywords
- PCI, Ticagrelor, Eptifibatide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Posted 28 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to measure platelet response to ticagrelor and eptifibatide bolus-only compared with ticagrelor and eptifibatide bolus plus 2-hour infusion administrated after cardiac catheterization in patients undergoing non-emergent percutaneous coronary intervention.
Detailed description
In this study, 70 patients with Acute Coronary Syndrome who are undergoing non-emergent percutaneous coronary intervention (PCI) will be randomized to ticagrelor loading dose and eptifibatide bolus-only versus ticagrelor loading dose and eptifibatide bolus plus 2 hour infusion administrated after cardiac catheterization, but before PCI. Platelet function testing will be performed at baseline and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor and Eptifibatide bolus | Active comparator | Drug: Ticagrelor, Drug: EptifibatideTicagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart) |
| Ticagrelor & Eptifibatide bolus+infusion | Active comparator | Drug: Ticagrelor, Drug: EptifibatideTicagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Provision of informed consent prior to any study specific procedures
- Males and females aged 19 years and older
- Congruent to the PLATO trial, at least two of the following three criteria have to be met:
- ST-segment changes on electrocardiography, indicating ischemia; (In electrocardiography, the ST segment connects the QRS complex and the T wave and has a duration of 0.080 to 0.120 sec (80 to 120 ms).
- a positive test of a biomarker, indicating myocardial necrosis; or one of several risk factors;
Key exclusion criteria (17 listed)
- Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Patients with active pathological bleeding or a history of intracranial bleeding;
- patients with planned to urgent coronary artery bypass graft surgery;
- severe hepatic impairment;
- concomitant therapy with a strong cytochrome P-450 3A inhibitors, where 3A is s subfamily of the cytochrome P450 superfamily of genes;
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: BrilintaTicagrelor loading dose | Drug | Ticagrelor & Eptifibatide bolus+infusion, Ticagrelor and Eptifibatide bolus |
| EptifibatideAlso: Integrilini.v. infusion | Drug | Ticagrelor & Eptifibatide bolus+infusion, Ticagrelor and Eptifibatide bolus |
Primary outcome
Change in Percent Inhibition of Platelet Aggregation (%IPA)
Time frame: Baseline and 2 hours
Change from baseline in %IPA at 2 hours after stimulation with 20µM ADP (µM-micromolar, ADP-Adenosine diphosphate), measured in blood by an aggregometer among patients randomized to ticagrelor and 2 boluses of eptifibatide vs. ticagrelor and 2 boluses plus infusion of eptifibatide.
3 secondary outcomes
High On-treatment Platelet Reactivity (HPR)
Time frame: Comparing baseline and follow-up (2 hours)
Bleeding Complications
Time frame: up to 24 hours
Periprocedural Myocardial Infarction (PMI)
Time frame: Up to 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28611098Marian MJ, Alli O, Al Solaiman F, Brott BC, Sasse M, Leesar T, Prabhu SD, Leesar MA. Ticagrelor and Eptifibatide Bolus Versus Ticagrelor and Eptifibatide Bolus With 2-Hour Infusion in High-Risk Acute Coronary Syndromes Patients Undergoing Early Percutaneous Coronary Intervention. J Am Heart Assoc. 2017 Jun 13;6(6):e005562. doi: 10.1161/JAHA.117.005562.
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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.
Massoud Leesar, MD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ticagrelor and Eptifibatide in people with Acute Coronary Syndrome, run by University of Alabama at Birmingham at 2 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 14 inclusion and 17 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 28 Feb 2017. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 Feb 2017). 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?
Change in Percent Inhibition of Platelet Aggregation (%IPA) (time frame: Baseline and 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01919723, which also lists 1 linked publication.
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 28 Feb 2017.