AzTrials
AzTrials

Cerebral InfarctionPhase 2NCT00684515

Trial to Assess the Safety of Vorapaxar in Japanese Subjects With Cerebral Infarction (P05005; MK-5348-017)

A Phase 2 study testing Vorapaxar 2.5 mg, Vorapaxar 1 mg and Aspirin 75-150 mg in people with Cerebral Infarction, run by Merck Sharp & Dohme LLC.

Completed

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

Official record
Search all trials

Trial summary

The study is designed to assess safety of Vorapaxar when added to standard of care (aspirin) in Japanese subjects with cerebral infarction. The study will assess incidence and tolerability of bleeding, major adverse cardiac events, all adverse events, and effect on expression of markers of inflammation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebral Infarction
What is being tested?
Vorapaxar 2.5 mg, Vorapaxar 1 mg and Aspirin 75-150 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
No sites listed yet
Study dates
21 Sep 2006to 8 Nov 2007
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women at least 18 years old with last cerebral infarction (excluding cardiogenic cerebral embolism) having occurred from 14 days to less than 1 year after onset (at the time of obtaining consent), with stable nervous system for more than 24 hours and known course of disease.
  • Participants confirmed to have cerebral infarction lesion by brain computerized tomography (CT) or magnetic resonance imaging (MRI).
  • Both of in-participant and out-participant
  • Willing to give appropriate informed consent and complete all study-related procedures and able to adhere to dosing and visit schedules.
  • Women of child-bearing potential (all postmenopausal women who are <1 year menopausal or who have not had surgical sterilization or a hysterectomy are considered to be women of child-bearing potential) must agree to use a medically accepted method of contraception while receiving protocol-specified study drug, and for 60 days after completion or discontinuation of the medication.

Who cannot join

  • Pregnancy and nursing patients (premenopausal women should have a negative pregnancy test result confirmed before enrollment)
  • Participant with any serious complication or any condition that the investigator feels that would cause a significant hazard to the participant if the study drug is administered.
  • Known hypersensitivity to any component of the study drug.
  • Participation in a study or use of an investigational study drug within 30 days before obtaining consent.
  • Member of the staff personnel directly involved with this study
  • Family member of the study staff.
Show all 19Show fewer
  • History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before obtaining consent.
  • History of cerebral hemorrhage.
  • Severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg).
  • Major surgery within 2 weeks before obtaining consent.
  • Known platelet count <100,000/mm^3
  • Participants confirmed to have cerebral bleeding or any causes of cerebral bleeding by brain CT or MRI.
  • Participants with transient ischemic attack (TIA), progressive stroke or cardiogenic cerebral embolism.
  • Known impairment of renal function (serum creatinine >2.0 mg/dL [>176.8 (umol/L]), dysproteinemia, nephrotic syndrome, or other renal disease
  • Active or chronic hepatobiliary system or hepatic disease, or aspartate aminotransferase (GOT) or alanine aminotransferate (GPT) activity more than two times greater than the upper limit of the laboratory normal range.
  • Participants with contraindictation to aspirin.
  • Scheduled to have PCI (peripheral coronary intervention), peripheral interventional event, carotid endarterectomy, intra- and extra- cranial bypass surgery and intravascular surgery (angioplasty) during the study period.
  • Combination therapy with unfractionated heparin, tissue plasminogen activator, urokinase, warfarin, factor Xa inhibitor, direct thrombin inhibitor or antiplatelet agents other than aspirin after obtaining consent, or scheduled to have the above combination therapy.
  • Any serious impairment which would make detection of new ischemic events difficult (eg, bedridden participants, participants with total nursing care, dementia participants, etc.) or consciousness disturbance which may cause aspiration of the study drug.

About this study

Official title: Phase II Study of SCH 530348 in Subjects With Cerebral Infarction

The study is designed to assess safety of Vorapaxar when added to standard of care (aspirin) in Japanese subjects with cerebral infarction. The study will assess incidence and tolerability of bleeding, major adverse cardiac events, all adverse events, and effect on expression of markers of inflammation.

Being tested
Vorapaxar 2.5 mg, Vorapaxar 1 mg, Placebo, Aspirin 75-150 mg
Medical subject headings
Cerebral Infarction

What participants receive

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

  • Vorapaxar 2.5 mgDrug

    Oral tablets; once daily for 60 days.

  • Vorapaxar 1 mgDrug

    Oral tablets; once daily for 60 days

  • PlaceboDrug

    oral tablets; once daily for 60 days

  • Aspirin 75-150 mgDrug

    oral tablets; once daily for 60 days

Study groups in NCT00684515
Study groupRoleWhat they receive
Vorapaxar 2.5 mg + AspirinExperimentalVorapaxar oral tablets; once daily for 60 days + Aspirin.
Receives: Drug: Vorapaxar 2.5 mg; Drug: Aspirin 75-150 mg
Vorapaxar 1 mg + AspirinExperimentalVorapaxar oral tablets; once daily for 60 days + Aspirin.
Receives: Drug: Vorapaxar 1 mg; Drug: Aspirin 75-150 mg
Placebo + AspirinPlacebo comparatorPlacebo oral tablets; once daily for 60 days + Aspirin
Receives: Drug: Placebo; Drug: Aspirin 75-150 mg

What is being measured

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

  1. Number of Participants Experiencing Non-Major Adverse Cardiac Events (Non-MACE)

    An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporarily associated with study drug administration, whether or not considered related to study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization. All MACE events were excluded from this analysis.

    Measured: Up to Day 121

Secondary outcomes (5)

  1. Number of Paticipants Experiencing Thrombolysis in Myocardial Infarction (TIMI) Major, Minor, and Non-TIMI Bleeding Events

    Major TIMI bleeding was defined as any intracranial bleeding (excluding micohemorrhages <10 mm evident on magnetic resonance imaging [MRI]), clinical over signs of hemorrhge associated with a drop in hemoglobin >=5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in a hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI or Minor TIMI bleeding.

    Measured: Up to Day 60

  2. Number of Participants With MACE or Death

    The number of participants experiencing major cardiac events or death was evaluated up to Day 121. Major cardiac events were defined as nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization.

    Measured: Up to Day 121

  3. Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels By Study Visit

    Participant blood samples were collected to determine the median serum level of hs-CRP. hs-cRP levels reflect the underlying level of inflammation. The higher the level, the greater the disease burden.

    Measured: Up to Day 60

  4. Mean CD40 Ligand Levels By Study Visit

    Participant blood samples were collected to determine the mean serum level of CD40 ligand. CD40 ligand values represent the level of disease activation with a higher level of CD40 ligand indicating a greater underlying risk.

    Measured: Up to Day 60

  5. Mean Membrane-Bound P-Selectin Levels By Study Visit

    Participant blood samples were collected at Baseline, Day 30, and Day 60 to determine the mean level of membrane-bound p-selectin in the serum. Membrane-bound P-selectin levels reflect the underlying level of inflammation. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels.

    Measured: Up to Day 60

Timeline

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

  1. First posted26 May 2008 (estimated)
  2. Study start21 Sep 2006
  3. Primary completion8 Nov 2007
  4. Study completion8 Nov 2007

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00684515
Sponsor's protocol ID
P05005
Status last verified
Aug 2018
First submitted
22 May 2008
Last updated
21 Sep 2018
Data monitoring committee
Yes
Individual data sharing
Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Shinohara Y, Goto S, Doi M, Jensen P. Safety of the novel protease-activated receptor-1 antagonist vorapaxar in Japanese patients with a history of ischemic stroke. J Stroke Cerebrovasc Dis. 2012 May;21(4):318-24. doi: 10.1016/j.jstrokecerebrovasdis.2010.09.005. Epub 2010 Oct 14.

    PubMed 20947374

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vorapaxar 2.5 mg, Vorapaxar 1 mg and Aspirin 75-150 mg in people with Cerebral Infarction, run by Merck Sharp & Dohme LLC.

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 5 inclusion and 19 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 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Jul 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?

Number of Participants Experiencing Non-Major Adverse Cardiac Events (Non-MACE) (time frame: Up to Day 121). 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 NCT00684515, which also lists 1 linked publication.

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 21 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in