AtherosclerosisPhase 2NCT00684203
Trial to Assess the Safety and Effects of Vorapaxar in Japanese Subjects With Acute Coronary Syndrome (P04772; MK-5348-016)
A Phase 2 study testing Vorapaxar, Aspirin and Clopidogrel in people with Atherosclerosis and Myocardial Ischemia, run by Merck Sharp & Dohme LLC.
Trial summary
The study is designed to assess safety and effects of vorapaxar, when added to standard of care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study may also provide information about the effect of vorapaxar on preventing heart attack and stroke in this subject population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Myocardial Ischemia, Myocardial Infarction
- What is being tested?
- Vorapaxar, Aspirin and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2006to 1 Oct 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 aged 18 years or more with history of cardiac ischemia related chest discomfort of > 10 minutes duration < 24 hours prior to randomization, and having at least 1 of the following A or B. Participants who are planned to undergo PCI will be the target participants.
- A: Positive biomarkers [Elevated troponin I or creatinine kinase MB isozyme greater than the site's upper limit of normal (ULN)] at or before registration
- B: Electrocardiogram (ECG) changes: ST segment depression >= 0.1 mV (>=1 mm), or transient (<30 minutes) ST segment elevation >= 0.1 mV (>=1 mm) in at least 2 contiguous leads
- Willing to give appropriate informed consent and complete all study-related procedures, and able to adhere to dosing and all visit schedules.
- Women of child-bearing potential (all postmenarchal women who are <1 years 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 medication, and for 60 days after stopping the medication.
Who cannot join
- Pregnant and nursing mothers (premenopausal women should have a negative pregnancy test result confirmed before enrollment)
- Any serious illness or any condition that the investigator feels would pose a significant hazard to the participant if investigational therapy were initiated
- known hypersensitivity to any component of the current investigational product;
- Participation in a study of experimental therapy or use of any investigational drug within 30 days before enrollment
- Member of the staff personnel directly involved with this study;
- Family member of the investigational study staff;
Show all 17Show fewer
- History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before enrollment
- History of a hemorrhagic stroke at any time
- Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) while receiving therapy;
- Major surgery within 2 weeks prior to enrollment
- Known platelet count <100,000/mm^3
- Uncontrolled cardiac arrhythmia;
- 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 or hepatic disease, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) activity more than two times greater than the upper limit of the laboratory reference range
- Anticipated staged PCI
- Concurrent or anticipated treatment with warfarin, factor Xa inhibitor, direct thrombin inhibitor, or antiplatelet agents except aspirin and ticlopidine after enrollment
- Anticipated intracoronary brachytherapy
About this study
Official title: Phase II Study of SCH 530348 in Subjects With Acute Coronary Syndrome
The study is designed to assess safety and effects of vorapaxar, when added to standard of care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study may also provide information about the effect of vorapaxar on preventing heart attack and stroke in this subject population.
Read the detailed description
The study drug (loading dose) is administered at least 1 hour before catheterization for diagnostic imaging or percutaneous coronary interventions (PCI). The incidence of bleeding is thought to be an important index to assess the safety of this drug, therefore thrombolysis in myocardial infarction (TIMI) is evaluated.
- Conditions
- Atherosclerosis, Myocardial Ischemia, Myocardial Infarction
- Being tested
- Vorapaxar, Placebo, Aspirin, Clopidogrel
- Medical subject headings
- Atherosclerosis, Myocardial Ischemia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VorapaxarDrug
Oral tablets; single 20-mg or 40-mg loading dose on first day followed by daily 1-mg or 2.5-mg maintenance dose for 59 days
PlaceboDrug
Oral tablets; matching placebo for SCH 530348 loading and maintenance doses for 59 days
AspirinDrug
Also called ASA, acetylsalicylic acid
Loading dose of 75-325 mg on Day 1, then 75-100 mg once daily for 60 days.
ClopidogrelDrug
100 mg two or three times daily for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| Vorapaxar 20 mg/1 mg | Experimental | Vorapaxar 20 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine) Receives: Drug: Vorapaxar; Drug: Aspirin; Drug: Clopidogrel |
| Vorapaxar 20 mg/2.5 mg | Experimental | Vorapaxar 20 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine) Receives: Drug: Vorapaxar; Drug: Aspirin; Drug: Clopidogrel |
| Vorapaxar 40 mg/1 mg | Experimental | Vorapaxar 40 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine) Receives: Drug: Vorapaxar; Drug: Aspirin; Drug: Clopidogrel |
| Vorapaxar 40 mg/2.5 mg | Experimental | Vorapaxar 40 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine) Receives: Drug: Vorapaxar; Drug: Aspirin; Drug: Clopidogrel |
| Placebo | Placebo comparator | Placebo loading dose + daily placebo maintenance dose + standard of care (Aspirin + Ticlopidine) Receives: Drug: Placebo; Drug: Aspirin; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI)
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.
Measured: Up to Day 60
Secondary outcomes (15)
Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading/maintenance dose group.
Measured: Up to Day 121
Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI
Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo magnetic resonance imaging [MRI]), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥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 hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by maintenance dose group.
Measured: Up to Day 60
Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit
Blood samples were collected from participants at Baseline and Days 30, 60, 74, 90, and 121 to determine the extent of inhibition of platelet aggregation induced by thrombin-receptor agonist peptide (TRAP). Analysis of data was by maintenance dose group.
Measured: Baseline, Day 30, Day 60, Day 74, Day 90, Day 121
Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit
Participant blood samples were collected at Baseline and on Days 30 and 60 to evaluate the median level of hs-CRP. hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation. Analysis of data was by maintenance dose group.
Measured: Baseline, Day 30, Day 60
Mean CD40 Ligand Levels Among Participants Who Underwent PCI
Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of CD40 ligand present. CD40 ligand is a protein primarily found on activated T-cells, with higher levels indicating better immunological health. Analysis of data was by maintenance dose group.
Measured: Baseline, Day 30, Day 60
Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI
Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of membrane-bound P-selectin. Membrane-bound P-selectin was measured using flow cytometry and a monoclonal antibody to P-selectin. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels. Analysis of data was by maintenance dose group.
Measured: Baseline, Day 30, Day 60
Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge
Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring hospitalization, or TIMI major bleeding. Analysis of data was by loading/maintenance dose group.
Measured: Up to Day 121
Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI
Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥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 hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by loading dose group.
Measured: Up to Day 60
Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal MI, nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading dose group.
Measured: Up to Day 121
Number of Participants Who Did Not Undergo PCI But Had Coronary Artery Bypass Graft (CABG) Who Experienced Bleeding Events
Bleeding events were evaluated up to 10 hours post-CABG among participants who did not undergo PCI.
Measured: Up to 10 Hours Post-CABG
Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion
Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants that required blood transfusion. Analysis of data was by loading dose group.
Measured: Up to Day 60
Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization
Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants who required a subsequent hospitalization. Analysis of data was by loading dose group.
Measured: Up to Day 30
Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI
Participant blood samples were collected at baseline and at the time of hospital discharge to determine the median serum level of hs-CRP. Analysis of data was by loading dose group.
Measured: Baseline Up To Day 60
Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI
Participant blood samples were collected at baseline and at the time of hospital discharge to determine the mean serum level of CD40 ligand. Analysis of data was by loading dose group.
Measured: Baseline Up To Day 60
Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events
Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring blood transfusion, bleeding requiring hospitalization, and TIMI major bleeding. Analysis of data was by loading dose group.
Measured: Baseline 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.
- First posted26 May 2008 (estimated)
- Study start1 Dec 2006
- Primary completion1 Oct 2007
- Study completion1 Oct 2007
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 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
- NCT00684203
- Sponsor's protocol ID
- P04772
- Status last verified
- Mar 2017
- First submitted
- 22 May 2008
- Last updated
- 5 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Goto S, Yamaguchi T, Ikeda Y, Kato K, Yamaguchi H, Jensen P. Safety and exploratory efficacy of the novel thrombin receptor (PAR-1) antagonist SCH530348 for non-ST-segment elevation acute coronary syndrome. J Atheroscler Thromb. 2010 Feb 26;17(2):156-64. doi: 10.5551/jat.3038. Epub 2010 Feb 3.
PubMed 20124733
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of SCH 530348 in Subjects With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT00684203
- Acronym / sponsor ID
- P04772
- Conditions
- Atherosclerosis, Myocardial Ischemia, Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2006 (actual)
- Primary completion
- 1 Oct 2007 (actual)
- Study completion
- 1 Oct 2007 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to assess safety and effects of vorapaxar, when added to standard of care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study may also provide information about the effect of vorapaxar on preventing heart attack and stroke in this subject population.
Detailed description
The study drug (loading dose) is administered at least 1 hour before catheterization for diagnostic imaging or percutaneous coronary interventions (PCI). The incidence of bleeding is thought to be an important index to assess the safety of this drug, therefore thrombolysis in myocardial infarction (TIMI) is evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Vorapaxar 20 mg/1 mg | Experimental | Drug: Vorapaxar, Drug: Aspirin, Drug: ClopidogrelVorapaxar 20 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine) |
| Vorapaxar 20 mg/2.5 mg | Experimental | Drug: Vorapaxar, Drug: Aspirin, Drug: ClopidogrelVorapaxar 20 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine) |
| Vorapaxar 40 mg/1 mg | Experimental | Drug: Vorapaxar, Drug: Aspirin, Drug: ClopidogrelVorapaxar 40 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine) |
| Vorapaxar 40 mg/2.5 mg | Experimental | Drug: Vorapaxar, Drug: Aspirin, Drug: ClopidogrelVorapaxar 40 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine) |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Aspirin, Drug: ClopidogrelPlacebo loading dose + daily placebo maintenance dose + standard of care (Aspirin + Ticlopidine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged 18 years or more with history of cardiac ischemia related chest discomfort of > 10 minutes duration < 24 hours prior to randomization, and having at least 1 of the following A or B. Participants who are planned to undergo PCI will be the target participants.
- Willing to give appropriate informed consent and complete all study-related procedures, and able to adhere to dosing and all visit schedules.
- Women of child-bearing potential (all postmenarchal women who are <1 years 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 medication, and for 60 days after stopping the medication.
Key exclusion criteria (17 listed)
- Pregnant and nursing mothers (premenopausal women should have a negative pregnancy test result confirmed before enrollment)
- Any serious illness or any condition that the investigator feels would pose a significant hazard to the participant if investigational therapy were initiated
- known hypersensitivity to any component of the current investigational product;
- Participation in a study of experimental therapy or use of any investigational drug within 30 days before enrollment
- Member of the staff personnel directly involved with this study;
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 |
|---|---|---|
| VorapaxarOral tablets; single 20-mg or 40-mg loading dose on first day followed by daily 1-mg or 2.5-mg maintenance dose for 59 days | Drug | Vorapaxar 20 mg/1 mg, Vorapaxar 20 mg/2.5 mg, Vorapaxar 40 mg/1 mg, Vorapaxar 40 mg/2.5 mg |
| PlaceboOral tablets; matching placebo for SCH 530348 loading and maintenance doses for 59 days | Drug | Placebo |
| AspirinAlso: ASA, acetylsalicylic acidLoading dose of 75-325 mg on Day 1, then 75-100 mg once daily for 60 days. | Drug | Placebo, Vorapaxar 20 mg/1 mg, Vorapaxar 20 mg/2.5 mg, Vorapaxar 40 mg/1 mg, Vorapaxar 40 mg/2.5 mg |
| Clopidogrel100 mg two or three times daily for 60 days. | Drug | Placebo, Vorapaxar 20 mg/1 mg, Vorapaxar 20 mg/2.5 mg, Vorapaxar 40 mg/1 mg, Vorapaxar 40 mg/2.5 mg |
Primary outcome
Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI)
Time frame: Up to Day 60
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.
15 secondary outcomes
Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI
Time frame: Up to Day 121
Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI
Time frame: Up to Day 60
Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit
Time frame: Baseline, Day 30, Day 60, Day 74, Day 90, Day 121
Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit
Time frame: Baseline, Day 30, Day 60
Mean CD40 Ligand Levels Among Participants Who Underwent PCI
Time frame: Baseline, Day 30, Day 60
Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI
Time frame: Baseline, Day 30, Day 60
Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge
Time frame: Up to Day 121
Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI
Time frame: Up to Day 60
Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI
Time frame: Up to Day 121
Number of Participants Who Did Not Undergo PCI But Had Coronary Artery Bypass Graft (CABG) Who Experienced Bleeding Events
Time frame: Up to 10 Hours Post-CABG
Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion
Time frame: Up to Day 60
Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization
Time frame: Up to Day 30
Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI
Time frame: Baseline Up To Day 60
Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI
Time frame: Baseline Up To Day 60
Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events
Time frame: Baseline Up To Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20124733Goto S, Yamaguchi T, Ikeda Y, Kato K, Yamaguchi H, Jensen P. Safety and exploratory efficacy of the novel thrombin receptor (PAR-1) antagonist SCH530348 for non-ST-segment elevation acute coronary syndrome. J Atheroscler Thromb. 2010 Feb 26;17(2):156-64. doi: 10.5551/jat.3038. Epub 2010 Feb 3.
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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 Vorapaxar, Aspirin and Clopidogrel in people with Atherosclerosis and Myocardial 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 5 inclusion and 17 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 5 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. 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 15 Aug 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 Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI) (time frame: Up to Day 60). 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 NCT00684203, 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 5 May 2017.