Phase 2
N=70
Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01919723 ↗Enrolled (actual)
70
Serious AEs
30.3%
Results posted
Feb 2017
Primary outcome: Primary: Change in Percent Inhibition of Platelet Aggregation (%IPA) — 99.59; 99.88 percentage of IPA
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ticagrelor (Drug); Eptifibatide (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percent Inhibition of Platelet Aggregation (%IPA) |
99.59; 99.88 | — |
| SECONDARY High On-treatment Platelet Reactivity (HPR) |
89; 79; 0; 0 | — |
| SECONDARY Bleeding Complications |
0; 1 | — |
| SECONDARY Periprocedural Myocardial Infarction (PMI) |
9; 7 | — |
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.
Eligibility Criteria
Inclusion Criteria
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;
- 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.
Exclusion Criteria
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;
- 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
Data sourced from ClinicalTrials.gov (NCT01919723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.