Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)

A Phase 3 study testing Vorapaxar 2.5 mg in people with Atherosclerosis and Ischemia, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

This study is designed to evaluate the long-term ocular safety of SCH 530348 (vorapaxar) in participants with established atherosclerotic disease who are enrolled into the TRA 2°P - TIMI 50 Study (P04737) (NCT00526474). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atherosclerosis, Ischemia, Myocardial Infarction
What is being tested?: Vorapaxar 2.5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 258 participants
Where: No sites listed yet
Study dates: 1 Jul 2008to 1 Oct 2010
Phase: Phase 3
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

Evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems

Who cannot join

The study will include participants who meet none of the exclusion criteria for the parent protocol (P04737) and also the following:
history or evidence of age-related macular degeneration on baseline evaluation
history of diabetic macular edema, or evidence of treated diabetic retinopathy on baseline evaluation
history or evidence of other retinal diseases, including retinal injury, on baseline evaluation
history or evidence of retinal surgery, including laser photocoagulation, on baseline evaluation
history or evidence of glaucoma on baseline evaluation

Show all 9Show fewer

history or evidence of high intraocular pressure of >22 mm Hg on baseline evaluation
evidence of center foveal thickness of >190 µm on baseline OCT examination
presence of vacuoles in the retina on baseline OCT

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Ocular Safety of SCH 530348 in Subjects Participating in the Schering-Plough P04737 Study (TRA^SM-Secondary Prevention Ocular Safety Study)

Conditions: Atherosclerosis, Ischemia, Myocardial Infarction, Cerebrovascular Accident
Being tested: Vorapaxar 2.5 mg, Placebo
Medical subject headings: Atherosclerosis, Ischemia, Myocardial Infarction, Stroke

What participants receive

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

Vorapaxar 2.5 mgDrug
Vorapaxar 2.5 mg oral tablet
PlaceboDrug
matching placebo oral tablet

Study groups in NCT00617123
Study group	Role	What they receive
Vorapaxar	Experimental	Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year Receives: Drug: Vorapaxar 2.5 mg
Placebo	Placebo comparator	Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year Receives: Drug: Placebo

What is being measured

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

Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)
Vacuolization is defined as the presence of more than one vacuole (defined as a clear, round structure in the INL of the retina of at least 30 microns in diameter) compared to baseline in either the left or right eye as evaluated by ocular coherence tomography (OCT).
Measured: Up to 12 months

Secondary outcomes (4)

Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline
Visual acuity was assessed in both eyes by best corrected visual acuity following standardized refraction. The best corrected visual acuity score is the number of letters on a standard visual acuity testing chart read correctly by a participant. A decrease in best corrected visual acuity score in the left and/or right eye indicates a worsening of vision.
Measured: Baseline and 4, 8 and 12 months
Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT
Center foveal thickness measured by OCT was evaluated for a change from baseline in greater than 15 microns in either the left or right eye.
Measured: Baseline and 4, 8 and 12 months
Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT
Individual OCT abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 84 (42 possible abnormalities per eye). Data are for the left and right eyes combined (score range: 0 to 84). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.
Measured: Baseline and 4, 8 and 12 months
Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography
Individual fundus photography abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 48 (24 possible abnomalities per eye). Data are for the left and right eyes combined (score range: 0 to 48). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.
Measured: Baseline and 4, 8 and 12 months

Timeline

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

1 Jul 20081 Oct 2010

First posted15 Feb 2008 (estimated)
Study start1 Jul 2008
Primary completion1 Oct 2010
Study completion1 Oct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AtherosclerosisStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 258 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00617123
Sponsor's protocol ID: P05183
Other IDs: MK-5348-018
Status last verified: Aug 2018
First submitted: 4 Feb 2008
Last updated: 21 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
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All Atherosclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Ocular Safety of SCH 530348 in Subjects Participating in the Schering-Plough P04737 Study (TRA^SM-Secondary Prevention Ocular Safety Study)
ClinicalTrials.gov ID: NCT00617123
Acronym / sponsor ID: P05183
Conditions: Atherosclerosis, Ischemia, Myocardial Infarction, Cerebrovascular Accident
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 258 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: The TIMI Study Group, Duke Clinical Research Institute
Study start: 1 Jul 2008 (actual)
Primary completion: 1 Oct 2010 (actual)
Study completion: 1 Oct 2010 (actual)
First posted: 15 Feb 2008 (estimated)
Results: Posted 14 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Vorapaxar	Experimental	Drug: Vorapaxar 2.5 mgParticipants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
Placebo	Placebo comparator	Drug: PlaceboParticipants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems

Key exclusion criteria (9 listed)

The study will include participants who meet none of the exclusion criteria for the parent protocol (P04737) and also the following:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vorapaxar 2.5 mgVorapaxar 2.5 mg oral tablet	Drug	Vorapaxar
Placebomatching placebo oral tablet	Drug	Placebo

Primary outcome

Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)
Time frame: Up to 12 months
Vacuolization is defined as the presence of more than one vacuole (defined as a clear, round structure in the INL of the retina of at least 30 microns in diameter) compared to baseline in either the left or right eye as evaluated by ocular coherence tomography (OCT).

4 secondary outcomes

Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline
Time frame: Baseline and 4, 8 and 12 months
Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT
Time frame: Baseline and 4, 8 and 12 months
Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT
Time frame: Baseline and 4, 8 and 12 months
Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography
Time frame: Baseline and 4, 8 and 12 months

Results and safety

Results posted to the registry on 14 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vorapaxar	137	98
Placebo	121	95

Primary outcome: Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)

Time frame: Up to 12 months. Number. Unit: participants

Measure	Vorapaxar n = 91	Placebo n = 86
4 months (n=91, n=86)	1	0
8 months (n=86, n=80)	1	0
12 months (n=77, n=78)	0	0

Population analysed: The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline vacuolation assessment.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vorapaxar	0 of 0	0 of 0	Not reported
Placebo	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Atherosclerosis

Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vorapaxar 2.5 mg in people with Atherosclerosis and Ischemia, 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 1 inclusion and 9 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 14 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 Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT) (time frame: Up to 12 months). 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 NCT00617123.

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.