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

This study has been completed.
Sponsor:
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

April 26, 2012
February 26, 2013
March 2012
February 2013   (final data collection date for primary outcome measure)
P2Y12 Reaction Units [ Time Frame: 7 days ] [ Designated as safety issue: No ]
P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay
Same as current
Complete list of historical versions of study NCT01587651 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease
A Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease: 2nd Switching Antiplatelet Agents

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)..

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • 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
  • Drug: Ticagrelor Maintenance Dose
    one 90mg film coated tablet
    Other Name: Brilinta
  • Experimental: Prasugrel Maintenance Dose
    Prasugrel 10 mg QD MD
    Intervention: Drug: Prasugrel Maintenance Dose
  • Active Comparator: Ticagrelor Maintenance Dose
    Ticagrelor 90 mg twice-daily (BID) MD
    Intervention: Drug: Ticagrelor Maintenance Dose
  • Experimental: Prasugrel Loading Dose
    Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)
    Interventions:
    • Drug: Prasugrel Loading Dose
    • Drug: Prasugrel Maintenance Dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT01587651
CS747s-B-U4003
No
Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
Eli Lilly and Company
Not Provided
Daiichi Sankyo Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP