Coronary Artery DiseaseNCT02256527
REWARDS Premier Taxus-Liberte vs Xience V
An observational study of Coronary Artery Disease, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
Multicenter, retrospective registry to collect baseline, clinical, procedural, in hospital and 9-12 month follow-up data to compare major adverse cardiac events in patients receiving Promus Premier drug eluting stent to data already collected from the REWARDS-TLX Registry in which patients received either the Taxus… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Observational
- How many people
- 917 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Oct 2015
- Phase
- Observational
- 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
Study population: Patients male or female, 18 years or older who have undergone percutaneous coronary intervention with Promus Premier (alone) drug eluting stent
Who may be able to join
- Patients 18 years of age or older
- Underwent PCI with Promus Premier (alone) DES
Who cannot join
- Underwent PCI with a non-Promus Premier DES during the same index procedure
- Patients not taking, or unable to take, dual antiplatelet therapy (aspirin plus clopidogrel, prasugrel, or ticagrelor)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: REWARDS-Premier TLX (Registry Experience at the WAshington Hospital CenteR, DeS - Premier Taxus-Liberte vs Xience V)
Multicenter, retrospective registry to collect baseline, clinical, procedural, in hospital and 9-12 month follow-up data to compare major adverse cardiac events in patients receiving Promus Premier drug eluting stent to data already collected from the REWARDS-TLX Registry in which patients received either the Taxus Liberte or XIENCE V drug eluting stent.
- Conditions
- Coronary Artery Disease
- Being tested
- Observational
- 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.
ObservationalOther
compare data
| Study group | Role | What they receive |
|---|---|---|
| Promus Premier | observational data Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac event
composite of all-cause death, Q-wave myocardial infarction, and target vessel revascularization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionOct 2015
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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 917 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256527
- Sponsor's protocol ID
- REWARDS Premier TLX
- Status last verified
- Jul 2016
- First submitted
- 1 Oct 2014
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REWARDS-Premier TLX (Registry Experience at the WAshington Hospital CenteR, DeS - Premier Taxus-Liberte vs Xience V)
- ClinicalTrials.gov ID
- NCT02256527
- Acronym / sponsor ID
- REWARDS Premier TLX
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 917 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Oct 2014 (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.
Multicenter, retrospective registry to collect baseline, clinical, procedural, in hospital and 9-12 month follow-up data to compare major adverse cardiac events in patients receiving Promus Premier drug eluting stent to data already collected from the REWARDS-TLX Registry in which patients received either the Taxus Liberte or XIENCE V drug eluting stent.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Promus Premier | – | Other: Observationalobservational data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients male or female, 18 years or older who have undergone percutaneous coronary intervention with Promus Premier (alone) drug eluting stent
Key inclusion criteria (2 listed)
- Patients 18 years of age or older
- Underwent PCI with Promus Premier (alone) DES
Key exclusion criteria (2 listed)
- Underwent PCI with a non-Promus Premier DES during the same index procedure
- Patients not taking, or unable to take, dual antiplatelet therapy (aspirin plus clopidogrel, prasugrel, or ticagrelor)
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 |
|---|---|---|
| Observationalcompare data | Other | Promus Premier |
Primary outcome
Major adverse cardiac event
Time frame: 1 year
composite of all-cause death, Q-wave myocardial infarction, and target vessel revascularization
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 14 Jul 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Medstar Health Research Institute at 1 site 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 2 inclusion and 2 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 14 Jul 2016. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Major adverse cardiac event (time frame: 1 year). 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 14 Jul 2016.