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Coronary Artery DiseasePhase 4SWAP-2NCT01587651

Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease

A Phase 4 study testing Prasugrel Loading Dose, Prasugrel Maintenance Dose and Ticagrelor Maintenance Dose in people with Coronary Artery Disease, run by Daiichi Sankyo at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Prasugrel Loading Dose, Prasugrel Maintenance Dose and Ticagrelor Maintenance Dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
13 sitesin 2 countries
Study dates
Mar 2012to Feb 2013
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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 locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

United States8 sites

  • Sinai Center for Thrombosis Research

    Baltimore, Maryland, 21215

  • Medpace Clinical Pharmacology Unit

    Cincinnati, Ohio, 45212

  • West Houston Area Clinical Trial Consultants

    Houston, Texas, 77094

  • Univ. of Florida College Medicine

    Jacksonville, Florida, 32209

  • Cardiology Center of Houston

    Katy, Texas, 77450

  • Clinical Pharmacology Unit of Miami

    Miami, Florida, 33014

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Black Hills Cardiovascular Research

    Rapid City, South Dakota, 57701

Other trials in United States

United Kingdom5 sites

  • Bristol Heart Institute

    Bristol, B52 8HW

  • University Hospital of Wales

    Heathpark, Cardiff, CF14 4XW

  • University Hospital Leicester

    Leicester, LE3 9QP

  • Southampton General Hospital

    Southampton, SO16 6YD

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

About this study

Official title: 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)..

Being tested
Prasugrel Loading Dose, Prasugrel Maintenance Dose, Ticagrelor Maintenance Dose
Keywords
CAD, prasugrel, ticagrelor, antiplatelet, thienopyridine, P2Y12 Inhibitors
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prasugrel Loading DoseDrug

    Also called Effient

    60mg given as six 10mg film coated tablets

  • Prasugrel Maintenance DoseDrug

    Also called Effient

    10mg maintenance dose, given as one 10mg film coated tablet

  • Ticagrelor Maintenance DoseDrug

    Also called Brilinta

    one 90mg film coated tablet

Study groups in NCT01587651
Study groupRoleWhat they receive
Prasugrel Maintenance DoseExperimentalPrasugrel 10 mg QD MD
Receives: Drug: Prasugrel Maintenance Dose
Ticagrelor Maintenance DoseActive comparatorTicagrelor 90 mg twice-daily (BID) MD
Receives: Drug: Ticagrelor Maintenance Dose
Prasugrel Loading DoseExperimentalPrasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)
Receives: Drug: Prasugrel Loading Dose; Drug: Prasugrel Maintenance Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. P2Y12 Reaction Units

    P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. Platelet aggregation with this system is defined by PRU, with a higher PRU indicative of greater platelet aggregation, and a lower PRU indicative of inhibition.

    Measured: 7 days after first randomized dose

Secondary outcomes (5)

  1. P2Y12 Reaction Units

    P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay measured at 2, 4, 24, 48 hours after first randomized study treatment

    Measured: 2, 4, 24, 48 hours after first randomized dose

  2. Platelet Reactivity Index

    Platelet Reactivity Index (PRI) by the Vasodilator-Stimulated Phosphoprotein(VASP) assay 2, 4, 24, 48 hours and 7 days after first randomized study treatment.

    The VASP assay is an indirect, but relatively specific measure of inhibition of P2Y12-induced platelet activation. The assay quantifies the level of phosphorylation of the intracellular protein VASP, which undergoes phosphorylation when platelet P2Y12 receptors are blocked. The level of VASP phosphorylation, expressed as the PRI, represents the percentage inhibition relative to an assay baseline/maximal P2Y12-independent platelet aggregation.

    Measured: 2, 4, 24, 48 hours, 7 days after first randomized dose

  3. PRU Percent Inhibition (Device-reported)

    PRU VerifyNow P2Y12 assay device-reported percent inhibition 2, 4, 24, and 48 hours, and 7 days after first randomized study treatment

    VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. The percent inhibition reported by VerifyNow device represents the percentage inhibition relative to maximal P2Y12-independent platelet aggregation achieved with the same sample in the presence of the iso-thrombin receptor activating peptide.

    Measured: 2, 4, 24, 48 hours, 7 days after first randomized dose

  4. PRU Percent Inhibition (Calculated)

    Analysis of Mean Calculated Percent Inhibition by time point

    Calculated percent inhibition at time point t is defined as: 100 × (baseline PRU - PRUt)/baseline PRU where baseline PRU is the VerifyNow PRU value at pre-run-in baseline and PRUt is the VerifyNow PRU value at time t.

    Measured: 2, 4, 24, 48 hours, 7 days after first randomized dose

  5. Percentage of Subjects With High On-treatment Platelet Reactivity

    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.

    A poor response of the platelets to "drug", called High Residual Platelet Reactivity (HRPR), has been incriminated to account for a recurrence of ischemic events

    Measured: 2, 4, 24, 48 hours, 7 days after first randomized dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01587651
Sponsor's protocol ID
CS747s-B-U4003
Acronym
SWAP-2
Status last verified
Mar 2014
First submitted
26 Apr 2012
Last updated
9 Jan 2019
Data monitoring committee
No
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prasugrel Loading Dose, Prasugrel Maintenance Dose and Ticagrelor Maintenance Dose in people with Coronary Artery Disease, run by Daiichi Sankyo at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

P2Y12 Reaction Units (time frame: 7 days after first randomized dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01587651.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.

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