Coronary Artery DiseasePhase 2NCT00312052
Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease
A Phase 2 study testing E5555 in people with Coronary Artery Disease, run by Eisai Inc. at 2 sites in United States.
Trial summary
The primary purpose of this study is to assess the safety and tolerability of E5555 in subjects with coronary artery disease. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- E5555
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 720 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to Aug 2009
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or Females, 45 - 80 years of age
- Confirmed coronary artery disease defined as one of the following:
- Post-acute coronary syndrome or myocardial infarction or
- Post percutaneous coronary intervention or coronary artery bypass graft or oAngina pectoris with documented (electrocardiogram or imaging study) ischemia or
- Angiographically documented lesion occluding ≥70% of a coronary vessel
- And at high risk as defined as one or more of the following:
Show all 11Show fewer
- Elevated hsCRP (high-sensitivity C-reactive protein)
- Diabetes mellitus
- History of carotid artery disease and/or peripheral artery disease
- Thrombo-embolic transient ischemic attack or stroke >1 year prior to screening
- All subjects must be receiving low dose aspirin and/or clopidogrel and/or ticlopidine.
Who cannot join
- History of acquired or congenital bleeding disorder, coagulopathy or platelet disorder, or history of pathological bleeding within the last 6 months
- History of intracranial bleeding, history of hemorrhagic retinopathy or known structural cerebral vascular lesion
- Clinically significant hematological, hepatic or renal abnormalities
- Patients with some specific ST-segment changes, severe congestive heart failure or uncontrolled cardiac arrhythmias at baseline
- Recent significant (as determined by the investigator) cardiovascular events
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Great Lakes Heart Center of Alpena
Alpena, Michigan, 49707
Florida Research Network
Gainesville, Florida, 32605
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease
The primary purpose of this study is to assess the safety and tolerability of E5555 in subjects with coronary artery disease.
Read the detailed description
This was a multicenter, randomized, double-blind, placebo-controlled trial of E5555, a PAR-1 inhibitor. The total duration of individual study participation was 28 weeks (196 days). This included a treatment period of 24 weeks (168 days) and a follow-up period of 4 weeks (28 days).
- Conditions
- Coronary Artery Disease
- Being tested
- E5555, Placebo
- Keywords
- Coronary Artery Disease
- 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.
E5555Drug
50 mg or 100 mg E5555 tablets
PlaceboDrug
50 mg and/or 100 mg placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| E5555 50 mg | Experimental | Participants received one 50 mg E5555 and two 100 mg placebo tablets, once orally daily for 24 weeks. Receives: Drug: E5555; Drug: Placebo |
| E5555 100 mg | Experimental | Participants received one 50 mg placebo, one 100 mg E5555 and one 100 mg placebo tablets, once orally daily for 24 weeks. Receives: Drug: E5555; Drug: Placebo |
| E5555 200 mg | Active comparator | Participants received one 50 mg placebo and two 100 mg E5555 tablets were taken orally once daily for 24 weeks. Receives: Drug: E5555; Drug: Placebo |
| Placebo | Placebo comparator | Participants received one 50 mg placebo and two 100 mg placebo tablets, once orally daily for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability - especially the risk of bleeding
Measured: 6 months
Secondary outcomes (1)
Incidence of major adverse cardiovascular events; the effect on platelet aggregation inhibition. Exploratory Outcome Measure: effects on endovascular inflammatory processes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2006 (estimated)
- Study startSep 2007
- Primary completionMar 2008
- Study completionAug 2009
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 Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Riefler, MD, Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312052
- Sponsor's protocol ID
- E5555-G000-201
- Other IDs
- 2005-006029-94, 2005
- Status last verified
- Nov 2016
- First submitted
- 5 Apr 2006
- Last updated
- 5 Dec 2016
- Results posted
- No
Publications
Wiviott SD, Flather MD, O'Donoghue ML, Goto S, Fitzgerald DJ, Cura F, Aylward P, Guetta V, Dudek D, Contant CF, Angiolillo DJ, Bhatt DL; LANCELOT-CAD Investigators. Randomized trial of atopaxar in the treatment of patients with coronary artery disease: the lessons from antagonizing the cellular effect of Thrombin-Coronary Artery Disease Trial. Circulation. 2011 May 3;123(17):1854-63. doi: 10.1161/CIRCULATIONAHA.110.001404. Epub 2011 Apr 18.
PubMed 21502571
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00312052
- Acronym / sponsor ID
- E5555-G000-201
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 7 Apr 2006 (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 primary purpose of this study is to assess the safety and tolerability of E5555 in subjects with coronary artery disease.
Detailed description
This was a multicenter, randomized, double-blind, placebo-controlled trial of E5555, a PAR-1 inhibitor. The total duration of individual study participation was 28 weeks (196 days). This included a treatment period of 24 weeks (168 days) and a follow-up period of 4 weeks (28 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| E5555 50 mg | Experimental | Drug: E5555, Drug: PlaceboParticipants received one 50 mg E5555 and two 100 mg placebo tablets, once orally daily for 24 weeks. |
| E5555 100 mg | Experimental | Drug: E5555, Drug: PlaceboParticipants received one 50 mg placebo, one 100 mg E5555 and one 100 mg placebo tablets, once orally daily for 24 weeks. |
| E5555 200 mg | Active comparator | Drug: E5555, Drug: PlaceboParticipants received one 50 mg placebo and two 100 mg E5555 tablets were taken orally once daily for 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received one 50 mg placebo and two 100 mg placebo tablets, once orally daily for 24 weeks. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males or Females, 45 - 80 years of age
- Confirmed coronary artery disease defined as one of the following:
- All subjects must be receiving low dose aspirin and/or clopidogrel and/or ticlopidine.
Key exclusion criteria (5 listed)
- History of acquired or congenital bleeding disorder, coagulopathy or platelet disorder, or history of pathological bleeding within the last 6 months
- History of intracranial bleeding, history of hemorrhagic retinopathy or known structural cerebral vascular lesion
- Clinically significant hematological, hepatic or renal abnormalities
- Patients with some specific ST-segment changes, severe congestive heart failure or uncontrolled cardiac arrhythmias at baseline
- Recent significant (as determined by the investigator) cardiovascular events
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 |
|---|---|---|
| E555550 mg or 100 mg E5555 tablets | Drug | E5555 100 mg, E5555 200 mg, E5555 50 mg |
| Placebo50 mg and/or 100 mg placebo tablets | Drug | E5555 100 mg, E5555 200 mg, E5555 50 mg, Placebo |
Primary outcome
Safety and tolerability - especially the risk of bleeding
Time frame: 6 months
1 secondary outcome
Incidence of major adverse cardiovascular events; the effect on platelet aggregation inhibition. Exploratory Outcome Measure: effects on endovascular inflammatory processes
Time frame: 6 months
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 5 Dec 2016.
- Derived from this study: PubMed 21502571Wiviott SD, Flather MD, O'Donoghue ML, Goto S, Fitzgerald DJ, Cura F, Aylward P, Guetta V, Dudek D, Contant CF, Angiolillo DJ, Bhatt DL; LANCELOT-CAD Investigators. Randomized trial of atopaxar in the treatment of patients with coronary artery disease: the lessons from antagonizing the cellular effect of Thrombin-Coronary Artery Disease Trial. Circulation. 2011 May 3;123(17):1854-63. doi: 10.1161/CIRCULATIONAHA.110.001404. Epub 2011 Apr 18.
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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.
John Riefler, MD study director
Eisai Limited
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E5555 in people with Coronary Artery Disease, run by Eisai Inc. at 2 sites in United States.
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 11 inclusion and 5 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 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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?
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?
Safety and tolerability - especially the risk of bleeding (time frame: 6 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 NCT00312052, 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 Dec 2016.