Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease (SWAP-2)
This study has been completed.
Sponsor:
Daiichi Sankyo Inc.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT01587651
First received: April 26, 2012
Last updated: February 26, 2013
Last verified: February 2013
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Purpose
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)..
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: Prasugrel Loading Dose Drug: Prasugrel Maintenance Dose Drug: Ticagrelor Maintenance Dose |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease: 2nd Switching Antiplatelet Agents |
Resource links provided by NLM:
MedlinePlus related topics:
Coronary Artery Disease
Drug Information available for:
Ticagrelor
U.S. FDA Resources
Further study details as provided by Daiichi Sankyo Inc.:
Primary Outcome Measures:
- P2Y12 Reaction Units [ Time Frame: 7 days ] [ Designated as safety issue: No ]P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay
Secondary Outcome Measures:
- P2Y12 Reaction Units [ Time Frame: 2, 4, 24, 48 hours ] [ Designated as safety issue: No ]P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay measured at 2, 4, 24, 48 hours after first randomized study treatment
- Platelet Reactivity Index [ Time Frame: 2, 4, 24, 48 hours, 7 days ] [ Designated as safety issue: No ]Platelet Reactivity Index (PRI) by the Vasodilator-Stimulated Phosphoprotein(VASP) assay 2, 4, 24, 48 hours and 7 days after first randomized study treatment.
- PRU percent inhibition [ Time Frame: 2, 4, 24, 48 hours, 7 days ] [ Designated as safety issue: No ]PRU VerifyNow P2Y12 assay device-reported and calculated percent inhibition 2, 4, 24, and 48 hours, and 7 days after first randomized study treatment
- Percentage of subjects with High on-treatment Platelet Reactivity [ Time Frame: 2, 4, 24, 48 hours, 7 days ] [ Designated as safety issue: No ]Percentage of subjects with High on-treatment Platelet Reactivity (HPR) defined as a) >= 208 PRU and b) >= 230 PRU by the VerifyNow P2Y12 assay and c) >50% PRI by the VASP assay, 2, 4, 24, and 48 hours and 7 days after first randomized study treatment
| Enrollment: | 110 |
| Study Start Date: | March 2012 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Prasugrel Maintenance Dose
Prasugrel 10 mg QD MD
|
Drug: Prasugrel Maintenance Dose
10mg maintenance dose, given as one 10mg film coated tablet
Other Name: Effient
|
|
Active Comparator: Ticagrelor Maintenance Dose
Ticagrelor 90 mg twice-daily (BID) MD
|
Drug: Ticagrelor Maintenance Dose
one 90mg film coated tablet
Other Name: Brilinta
|
|
Experimental: Prasugrel Loading Dose
Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)
|
Drug: Prasugrel Loading Dose
60mg given as six 10mg film coated tablets
Other Name: Effient
Drug: Prasugrel Maintenance Dose
10mg maintenance dose, given as one 10mg film coated tablet
Other Name: Effient
|
Eligibility| Ages Eligible for Study: | 18 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female; age >= 18 and < 75 years
- Weight >= 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 =< 12 months of an acute coronary syndrome (ACS) event (unstable angina [UA], non-ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]) regardless of initial treatment (that is, invasive versus noninvasive)
- Subjects who underwent angioplasty within 12 months including bare-metal stent and/or a drug-eluting stent
- Had any stent placed in an unprotected left main coronary artery or in the last patent artery within the last 12 months
- Received thienopyridine therapy within 30 days of study entry
- Plan to undergo coronary revascularization at any time during the trial
- Presence or history of any of the following: ischemic or hemorrhagic stroke; transient ischemic attack (TIA); intracranial neoplasm; arteriovenous malformation, or aneurysm; intracranial hemorrhage; head trauma (within 3 months of study entry)
- History of refractory ventricular arrhythmias with an increased risk of bradycardic events (eg, subjects without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree atrioventricular (AV) block or bradycardic-related syncope)
- History or evidence of congestive heart failure (New York Heart Association Class III or above =< 6 months before screening
- Severe hepatic impairment
- History of uric acid nephropathy
- Uncontrolled hypertension, or systolic blood pressure > 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587651
Locations
| United States, Florida | |
| Univ. of Florida College Medicine | |
| Jacksonville, Florida, United States, 32209 | |
| Clinical Pharmacology Unit of Miami | |
| Miami, Florida, United States, 33014 | |
| Progressive Medical Research | |
| Port Orange, Florida, United States, 32127 | |
| United States, Maryland | |
| Sinai Center for Thrombosis Research | |
| Baltimore, Maryland, United States, 21215 | |
| United States, Ohio | |
| Medpace Clinical Pharmacology Unit | |
| Cincinnati, Ohio, United States, 45212 | |
| United States, South Dakota | |
| Black Hills Cardiovascular Research | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Texas | |
| West Houston Area Clinical Trial Consultants | |
| Houston, Texas, United States, 77094 | |
| Cardiology Center of Houston | |
| Katy, Texas, United States, 77450 | |
| United Kingdom | |
| University Hospital of Wales | |
| Heath Park, Cardiff, United Kingdom, CF14 4XW | |
| Bristol Heart Institute | |
| Bristol, United Kingdom, B52 8HW | |
| University Hospital Leicester | |
| Leicester, United Kingdom, LE3 9QP | |
| Southampton General Hospital | |
| Southampton, United Kingdom, SO16 6YD | |
| New Cross Hospital | |
| Wolverhampton, United Kingdom, WV10 0QP | |
Sponsors and Collaborators
Daiichi Sankyo Inc.
Eli Lilly and Company
More Information
No publications provided
| Responsible Party: | Daiichi Sankyo Inc. |
| ClinicalTrials.gov Identifier: | NCT01587651 History of Changes |
| Other Study ID Numbers: | CS747s-B-U4003 |
| Study First Received: | April 26, 2012 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Daiichi Sankyo Inc.:
|
CAD prasugrel ticagrelor |
antiplatelet thienopyridine P2Y12 Inhibitors |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Platelet Aggregation Inhibitors Prasugrel Ticagrelor |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 13, 2013