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Phase 2 N=70 Randomized Treatment

Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion

Acute Coronary Syndrome

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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