Arterial Obstructive DiseasesPhase 2NCT00132912
Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)
A Phase 2 study testing SCH 530348 in people with Arterial Obstructive Diseases and Coronary Disease, run by Merck Sharp & Dohme LLC.
Trial summary
The object of the study is to determine whether different doses of SCH 530348, when added to standard medical care in persons undergoing percutaneous coronary intervention, will increase the risk of bleeding. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Arterial Obstructive Diseases, Coronary Disease
- What is being tested?
- SCH 530348
- How many people
- 1,030 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2005to 28 Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A person who is 45 years or older and is mentally competent to provide a signed written informed consent.
- A person who is scheduled to undergo a percutaneous coronary intervention or a heart catheterization with the intent to undergo a percutaneous coronary intervention.
- If a woman is of childbearing potential (ie, before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.
Who cannot join
- Pregnancy
- Recent stroke
- Active internal bleeding or a history of a bleeding disorder
- Increased risk of bleeding
- Severe high blood pressure
- Liver or kidney disease
Show all 11Show fewer
- Low platelet count
- Condition such as alcoholism, mental illness, or drug dependence
- Ongoing chest pain
- Planned or ongoing treatment with a blood thinning medication
- A serious condition or illness that would interfere with participation in the study
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention
The object of the study is to determine whether different doses of SCH 530348, when added to standard medical care in persons undergoing percutaneous coronary intervention, will increase the risk of bleeding.
A secondary objective is to determine whether patients treated with SCH 530348 have fewer cardiac events such as heart attack, bypass surgery, or death compared with those persons treated with the standard of care.
- Conditions
- Arterial Obstructive Diseases, Coronary Disease
- Being tested
- SCH 530348
- Keywords
- Platelets, Platelet Aggregation Inhibitors, Protease-Activated Receptor 1, Hemorrhage
- Medical subject headings
- Arterial Occlusive Diseases, Coronary Disease, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 530348Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention
Secondary outcomes (2)
Incidence of bleeding throughout treatment and follow-up
Incidence of death and major adverse cardiac events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study start30 Aug 2005
- Primary completion28 Jan 2007
- Study completion28 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial Obstructive DiseasesStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,030 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132912
- Sponsor's protocol ID
- P03573
- Status last verified
- May 2017
- First submitted
- 19 Aug 2005
- Last updated
- 25 May 2017
- Results posted
- No
Publications
Becker RC, Moliterno DJ, Jennings LK, Pieper KS, Pei J, Niederman A, Ziada KM, Berman G, Strony J, Joseph D, Mahaffey KW, Van de Werf F, Veltri E, Harrington RA; TRA-PCI Investigators. Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study. Lancet. 2009 Mar 14;373(9667):919-28. doi: 10.1016/S0140-6736(09)60230-0.
PubMed 19286091
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT00132912
- Acronym / sponsor ID
- P03573
- Conditions
- Arterial Obstructive Diseases, Coronary Disease
- Keywords
- Platelets, Platelet Aggregation Inhibitors, Protease-Activated Receptor 1, Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,030 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2005 (actual)
- Primary completion
- 28 Jan 2007 (actual)
- Study completion
- 28 Jan 2007 (actual)
- First posted
- 22 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The object of the study is to determine whether different doses of SCH 530348, when added to standard medical care in persons undergoing percutaneous coronary intervention, will increase the risk of bleeding.
A secondary objective is to determine whether patients treated with SCH 530348 have fewer cardiac events such as heart attack, bypass surgery, or death compared with those persons treated with the standard of care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A person who is 45 years or older and is mentally competent to provide a signed written informed consent.
- A person who is scheduled to undergo a percutaneous coronary intervention or a heart catheterization with the intent to undergo a percutaneous coronary intervention.
- If a woman is of childbearing potential (ie, before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.
Key exclusion criteria (11 listed)
- Pregnancy
- Recent stroke
- Active internal bleeding or a history of a bleeding disorder
- Increased risk of bleeding
- Severe high blood pressure
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 |
|---|---|---|
| SCH 530348 | Drug | – |
Primary outcome
Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention
2 secondary outcomes
Incidence of bleeding throughout treatment and follow-up
Incidence of death and major adverse cardiac events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Derived from this study: PubMed 19286091Becker RC, Moliterno DJ, Jennings LK, Pieper KS, Pei J, Niederman A, Ziada KM, Berman G, Strony J, Joseph D, Mahaffey KW, Van de Werf F, Veltri E, Harrington RA; TRA-PCI Investigators. Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study. Lancet. 2009 Mar 14;373(9667):919-28. doi: 10.1016/S0140-6736(09)60230-0.
- Click here to access a synopsis of the study results.Link provided by the sponsor.
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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 2 study testing SCH 530348 in people with Arterial Obstructive Diseases and Coronary Disease, 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 3 inclusion and 11 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 25 May 2017. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention. 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 NCT00132912, 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 25 May 2017.