Rate of AnginaNCT02455817
REWARDS-Angina at Follow up Post Stenting
An observational study of Rate of Angina, run by Medstar Health Research Institute.
Trial summary
Single center, retrospective registry to collect data regarding the rate of angina (any and CCS clas III/IV) within 12 months post stent implantation. In addition, the target vessel revascularization rate within 12 months post stent implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rate of Angina
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jun 2016
- 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 received at least one commercially available Drug Eluting Stent or Bare Metal Stent: Cypher, Taxus Express, Xience V, Promus Element, Resolute, or Bare Metal Stents
Who may be able to join
- Patients, male or female, > 18 years of age,
- Patients who received at least one (1) commercially available Drug Eluting Stent or Bare Metal Stent: Cypher, Taxus Express, Xience V, Promus Element, Resolute, or Bare Metal Stents
Who cannot join
- Received more than one type of DES as listed above or both a BMS and DES (as listed above)
About this study
Single center, retrospective registry to collect data regarding the rate of angina (any and CCS clas III/IV) within 12 months post stent implantation. In addition, the target vessel revascularization rate within 12 months post stent implantation.
Read the detailed description
The objective of this study is to retrospectively identify the rate of angina (any as well as CCS class III/IV) up to one (1) year following stent implantation. The following drug eluting stents will be evaluated in addition to bare metal stents; Cypher, Taxus Express, Xience V, Resolute and Promus Element. The target vessel revascularization rate will also be compared for the 6 stent types within one (1) year.
- Conditions
- Rate of Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cypher | Access rate of angina including degree, post PCI up to 1 year for the Cypher stent. | |
| Taxus Express | Access rate of angina including degree, post PCI up to 1 year for the Taxus Express stent. | |
| Xience V | Access rate of angina including degree, post PCI up to 1 year for the Xience V stent. | |
| Promus Element | Access rate of angina including degree, post PCI up to 1 year for the Promus stent. | |
| Resolute | Access rate of angina including degree, post PCI up to 1 year for the Resolute stent. | |
| Bare metal stents | Access rate of angina including degree, post PCI up to 1 year for bare metal stents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Angina
post PCI for a variety of DES and BMS
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rate of AnginaStudies 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
- 0 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
- NCT02455817
- Sponsor's protocol ID
- REWARDS- Angina
- Status last verified
- Jun 2018
- First submitted
- 26 May 2015
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REWARDS-Angina at Follow up Post Stenting
- ClinicalTrials.gov ID
- NCT02455817
- Acronym / sponsor ID
- REWARDS- Angina
- Conditions
- Rate of Angina
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 28 May 2015 (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.
Single center, retrospective registry to collect data regarding the rate of angina (any and CCS clas III/IV) within 12 months post stent implantation. In addition, the target vessel revascularization rate within 12 months post stent implantation.
Detailed description
The objective of this study is to retrospectively identify the rate of angina (any as well as CCS class III/IV) up to one (1) year following stent implantation. The following drug eluting stents will be evaluated in addition to bare metal stents; Cypher, Taxus Express, Xience V, Resolute and Promus Element. The target vessel revascularization rate will also be compared for the 6 stent types within one (1) year.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cypher | – | –Access rate of angina including degree, post PCI up to 1 year for the Cypher stent. |
| Taxus Express | – | –Access rate of angina including degree, post PCI up to 1 year for the Taxus Express stent. |
| Xience V | – | –Access rate of angina including degree, post PCI up to 1 year for the Xience V stent. |
| Promus Element | – | –Access rate of angina including degree, post PCI up to 1 year for the Promus stent. |
| Resolute | – | –Access rate of angina including degree, post PCI up to 1 year for the Resolute stent. |
| Bare metal stents | – | –Access rate of angina including degree, post PCI up to 1 year for bare metal stents. |
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 received at least one commercially available Drug Eluting Stent or Bare Metal Stent: Cypher, Taxus Express, Xience V, Promus Element, Resolute, or Bare Metal Stents
Key inclusion criteria (2 listed)
- Patients, male or female, > 18 years of age,
- Patients who received at least one (1) commercially available Drug Eluting Stent or Bare Metal Stent: Cypher, Taxus Express, Xience V, Promus Element, Resolute, or Bare Metal Stents
Key exclusion criteria (1 listed)
- Received more than one type of DES as listed above or both a BMS and DES (as listed above)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Angina
Time frame: up to 1 year
post PCI for a variety of DES and BMS
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
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?
An observational study of Rate of Angina, run by Medstar Health Research Institute.
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 1 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: withdrawn, as of the sponsor's last update on 12 Oct 2020. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of Angina (time frame: up to 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 12 Oct 2020.