Coronary Artery DiseasePhase 3NCT00426049
Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation
A Phase 3 study testing Everolimus in people with Coronary Artery Disease and Coronary Restenosis, run by German Heart Institute at 1 site in Germany.
Trial summary
The purpose of the present study is to provide the first in-human safety and efficacy evaluations of systemic oral anti-proliferative Everolimus therapy compared to placebo in patients treated by bare metal stents for significant coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Restenosis
- What is being tested?
- Everolimus
- How many people
- 484 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to not given
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, aged >18 years.
- Patients with coronary artery disease who are scheduled for coronary intervention with bare metal stent placement for treatment of de novo or first restenosis in a native coronary artery.
- Target lesion must be in a native coronary vessel of 2.25 - 4.0 mm size.
- Target lesion has to be of less than or equal to 25 mm length.
- Tandem lesion may be included as long as:
- overall length is less than or equal to 25 mm
- tandem lesion will be treated with one stent and counted as one lesion.
Who cannot join
- The following exclusion criteria must not be present at Baseline visit 1 (BL1, Screening visit prior to coronary intervention). If an exclusion criterion occurred afterwards, e.g., during the coronary intervention, the patient must be excluded from the study.
- Target lesion has a reference vessel size of less than 2.25 or more than 4.0 mm diameter.
- Target lesion is a total occlusion or located at a bifurcation.
- Treatment affords implantation of more than one stent per treated lesion.
- Target lesion was already treated by brachytherapy.
- Target lesion has one or more of the following criteria:
Show all 10Show fewer
- Left main lesion
- Ostial lesion of the RCA
- Located at less than 2 mm after the origin of the LAD or RCX.
- Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
German Heart Institute Berlin
Berlin, State of Berlin, 13353
Eckart Fleck, Professor
About this study
Official title: Monocenter, Double Blinded, Prospective, Randomized Placebo Controlled Study Investigating Prevention of Major Adverse Cardiac Events (MACEs) Within 6 Months by Systemic Treatment With Everolimus After Coronary Intervention With Bare Metal Stents in Patients With Significant Coronary Artery Disease
The purpose of the present study is to provide the first in-human safety and efficacy evaluations of systemic oral anti-proliferative Everolimus therapy compared to placebo in patients treated by bare metal stents for significant coronary artery disease. The aim is to reduce Major Adverse Cardiac Events (MACEs) including death, coronary artery bypass grafting (CABG) to the target vessel, Q-wave and non-Q-wave myocardial infarction, and target lesion revascularization within the first 6 months after intervention. Additionally safety and tolerability of Everolimus at the selected dose in this patient population will be analyzed.
- Conditions
- Coronary Artery Disease, Coronary Restenosis
- Being tested
- Everolimus
- Keywords
- Coronary artery disease, Stents, Immunosuppressive Agents, Coronary restenosis, Safety
- Medical subject headings
- Coronary Artery Disease, Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (MACEs)within 6 months
Secondary outcomes (4)
MACEs within 30 days
Quantitative angiographic observations within the vessel after 6 months
TLR and TVR after 6 months
Drug safety and tolerability for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2007 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 484 participants
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Eckart Fleck, Professor, Principal investigator, German Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426049
- Sponsor's protocol ID
- CRAD001ADE07
- Status last verified
- Jan 2007
- First submitted
- 23 Jan 2007
- Last updated
- 24 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocenter, Double Blinded, Prospective, Randomized Placebo Controlled Study Investigating Prevention of Major Adverse Cardiac Events (MACEs) Within 6 Months by Systemic Treatment With Everolimus After Coronary Intervention With Bare Metal Stents in Patients With Significant Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00426049
- Acronym / sponsor ID
- CRAD001ADE07
- Conditions
- Coronary Artery Disease, Coronary Restenosis
- Keywords
- Coronary artery disease, Stents, Immunosuppressive Agents, Coronary restenosis, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 484 participants
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Oct 2006
- First posted
- 24 Jan 2007 (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 purpose of the present study is to provide the first in-human safety and efficacy evaluations of systemic oral anti-proliferative Everolimus therapy compared to placebo in patients treated by bare metal stents for significant coronary artery disease. The aim is to reduce Major Adverse Cardiac Events (MACEs) including death, coronary artery bypass grafting (CABG) to the target vessel, Q-wave and non-Q-wave myocardial infarction, and target lesion revascularization within the first 6 months after intervention. Additionally safety and tolerability of Everolimus at the selected dose in this patient population will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females, aged >18 years.
- Patients with coronary artery disease who are scheduled for coronary intervention with bare metal stent placement for treatment of de novo or first restenosis in a native coronary artery.
- Target lesion must be in a native coronary vessel of 2.25 - 4.0 mm size.
- Target lesion has to be of less than or equal to 25 mm length.
- Tandem lesion may be included as long as:
Key exclusion criteria (10 listed)
- The following exclusion criteria must not be present at Baseline visit 1 (BL1, Screening visit prior to coronary intervention). If an exclusion criterion occurred afterwards, e.g., during the coronary intervention, the patient must be excluded from the study.
- Target lesion has a reference vessel size of less than 2.25 or more than 4.0 mm diameter.
- Target lesion is a total occlusion or located at a bifurcation.
- Treatment affords implantation of more than one stent per treated lesion.
- Target lesion was already treated by brachytherapy.
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 |
|---|---|---|
| Everolimus | Drug | – |
Primary outcome
Major adverse cardiac events (MACEs)within 6 months
4 secondary outcomes
MACEs within 30 days
Quantitative angiographic observations within the vessel after 6 months
TLR and TVR after 6 months
Drug safety and tolerability for 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2007.
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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.
Eckart Fleck, Professor principal investigator
German Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Everolimus in people with Coronary Artery Disease and Coronary Restenosis, run by German Heart Institute at 1 site in Germany.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 24 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eckart Fleck, Professor (+49-(0)30-4593 ext. 2400, fleck@dhzb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (MACEs)within 6 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2007.