Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease (SWAP-2)

Daiichi Sankyo

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Prasugrel Maintenance Dose; Drug: Prasugrel Loading Dose; Drug: Ticagrelor Maintenance Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01587651

CS747s-B-U4003

Details and patient eligibility

About

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)..

Enrollment: 110 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 3 patient groups

Prasugrel Maintenance Dose

Experimental group

Description:

Prasugrel 10 mg QD MD

Treatment:

Drug: Prasugrel Maintenance Dose

Ticagrelor Maintenance Dose

Active Comparator group

Description:

Ticagrelor 90 mg twice-daily (BID) MD

Treatment:

Drug: Ticagrelor Maintenance Dose

Prasugrel Loading Dose

Experimental group

Description:

Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)

Treatment:

Drug: Prasugrel Loading Dose

Drug: Prasugrel Maintenance Dose