Phase 4
N=15
Antithrombotic Effects of Ticagrelor Versus Clopidogrel
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01642238 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Platelet-thrombus Formation in an ex Vivo Model of Thrombosis — 56.3; 35.2 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ticagrelor + ASA + Bivalirudin (Drug); Clopidogrel + ASA + Bivalirudin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Juan J Badimon
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Platelet-thrombus Formation in an ex Vivo Model of Thrombosis |
34.1; 18.5 | — |
| PRIMARY Platelet-thrombus Formation in an ex Vivo Model of Thrombosis |
34.1; 18.5 | — |
| SECONDARY Platelet Reactivity |
67.4; 53.4 | — |
| SECONDARY Platelet Reactivity |
67.4; 53.4 | — |
| SECONDARY Platelet Reactivity |
67.4; 53.4 | — |
| SECONDARY Blood Thrombogenicity |
56.1; 54.3 | — |
| SECONDARY Blood Thrombogenicity |
56.1; 54.3 | — |
| SECONDARY Blood Thrombogenicity |
56.1; 54.3 | — |
Summary
The purpose of this study is to determine whether treatment with ticagrelor (plus aspirin and bivalirudin) is more effective than treatment with clopidogrel (plus aspirin and bivalirudin).
Eligibility Criteria
Inclusion Criteria
- Male or female volunteers between 18 and 65 years old.
- Body mass index (BMI) 18 - 30 kg/m2 inclusive.
- Healthy as assessed by a detailed medical history and physical examination.
- Laboratory est results within the normal range.
- Ability to provide signed informed consent.
Exclusion Criteria
- History of clinically relevant disease, bleeding, acute infectious disease or signs of acute illness.
- Allergy or hypersensitivity to aspirin or thienopyridines, or atopy diagnosed by a physician.
- Use of medication within one month prior to study drug administration.
- History of drug abuse or alcohol consumption >20 g/day.
- Inability to abstain from intensive muscular effort or sport competition.
- Loss of >400 mL blood or blood donation within 3 months.
- Positive serology for hepatitis B (HBs Ag) or hepatitis C.
- Conditions associated with hemorrhagic risk.
- Positive pregnancy test.
Data sourced from ClinicalTrials.gov (NCT01642238). 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.