Phase 4
Completed N=110
Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease
Source: ClinicalTrials.gov NCT01587651 ↗Enrolled (actual)
110
Serious AEs
0.9%
Results posted
Apr 2014
Primary outcomePrimary: P2Y12 Reaction Units — 95.0; 49.0 PRU (P2Y12 Reaction Units)
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)..
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 | — |
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. Informational only — not medical advice.