Phase 4
N=110
Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01587651 ↗Enrolled (actual)
110
Serious AEs
0.9%
Results posted
Apr 2014
Primary outcome: Primary: P2Y12 Reaction Units — 95.0; 49.0 PRU (P2Y12 Reaction Units)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prasugrel Loading Dose (Drug); Prasugrel Maintenance Dose (Drug); Ticagrelor Maintenance Dose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY P2Y12 Reaction Units |
33.7; 28.9; 22.1; 44.8; 41.1; 29.3 | — |
| SECONDARY P2Y12 Reaction Units |
33.7; 28.9; 22.1; 44.8; 41.1; 29.3 | — |
| SECONDARY Platelet Reactivity Index |
18.2; 13.2; 15.8; 20.4; 16.3; 14.3 | — |
| SECONDARY PRU Percent Inhibition (Device-reported) |
87.8; 89.2; 91.4; 84.3; 84.9; 89.6 | — |
| SECONDARY PRU Percent Inhibition (Calculated) |
88.22; 89.73; 92.55; 84.15; 85.06; 89.26 | — |
| SECONDARY Percentage of Subjects With High On-treatment Platelet Reactivity |
0; 0; 0; 0; 0; 0 | — |
Summary
This is a Phase 4, multicenter, open-label (blinded Pharmacodynamic PD results), randomized, 3-arm, parallel-design study of subjects with stable Coronary Artery Disease CAD. This study will compare the PD effect of prasugrel 10 mg QD (once-daily) maintenance dose with ticagrelor 90 mg BID (twice daily) maintenance dose in subjects with stable CAD who have previously received ticagrelor loading does (LD) and maintenance dose (MD)..
Eligibility Criteria
Inclusion Criteria
- Male or female; age >= 18 and = 60 kg
- Receiving low dose ASA (75 mg to 150 mg daily) for at least 7 days at the time of Visit 1 and able to continue the same regimen throughout the study
- Stable CAD. CAD is defined as any of the following:
- History of a positive stress test
- Previous coronary revascularization including percutaneous coronary intervention (PCI), stent, or coronary artery bypass graft (CABG)
- Angiographic demonstration of CAD (at least
1 lesion >= 50 percent)
- Presence of at least moderate plaque by computed tomography (CT) angiography
- Electron beam CT coronary artery calcification score >= 100 Agatston units
- If female, may be enrolled if
One of the following 3 criteria are met:
- Had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form (ICF)
- Post-menopausal for at least 1 year
- If of childbearing potential, will practice 1 of the following methods of birth control throughout the study: oral, injectable, or implantable hormonal contraceptives; intrauterine device; diaphragm plus spermicide; or female condom plus spermicide. Methods of contraception that are not acceptable are partner's use of condoms or partner's vasectomy
- Able and willing to provide written informed consent before entering the study
Exclusion Criteria
- Have a defined need for adenosine diphosphate (ADP)-receptor inhibitor therapy, such as any of the following (or any other condition that in the Investigator's judgment would require such therapy):
- Within = 180 mmHg or diastolic blood pressure > 110 mmHg at screening
- Severely impaired renal function (glomerular filtration rate < 30 mL/minute) or on dialysis
- At risk for bleeding
- Taking prohibited medications
Data sourced from ClinicalTrials.gov (NCT01587651). 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.