Percutaneous Coronary InterventionPhase 3CALIFORNIANCT02448550
Comparison of Anticoagulation for All-comers Undergoing Percutaneous Coronary Revascularization Trial
A Phase 3 study testing Bivalirudin and Unfractionated heparin in people with Percutaneous Coronary Intervention, run by Kaiser Permanente at 1 site in United States.
Trial summary
The purpose of this trial is to determine whether bivalirudin is non-inferior to unfractionated heparin in patients with stable angina, unstable angina, or non-ST segment elevation myocardial infarction undergoing percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- Bivalirudin and Unfractionated heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 16 Jun 2016
- 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
- Undergoing PCI for stable angina, unstable angina, or non-ST segment elevation myocardial infarction.
- Age 18 years or older.
Who cannot join
- Inability to obtain consent
- Emergency cardiac catheterization for ST-segment elevation myocardial infarction.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
About this study
Official title: Comparison of Unfractionated Heparin and Bivalirudin for Percutaneous Coronary Intervention for Stable Angina, Unstable Angina, and Non-ST Segment Elevation Myocardial Infarction
The purpose of this trial is to determine whether bivalirudin is non-inferior to unfractionated heparin in patients with stable angina, unstable angina, or non-ST segment elevation myocardial infarction undergoing percutaneous coronary intervention.
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- Bivalirudin, Unfractionated heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BivalirudinDrug
Unfractionated heparinDrug
| Study group | Role | What they receive |
|---|---|---|
| bivalirudin | Experimental | Bivalirudin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted. Receives: Drug: Bivalirudin |
| unfractionated heparin | Active comparator | Unfractionated heparin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted. Receives: Drug: Unfractionated heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints)
Measured: 30-days
Secondary outcomes (2)
all cause mortality, myocardial infarction, or unplanned revascularization for ischemia
Measured: 30-days
Bleeding Academic Research Consortium grade III or V bleeding events
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startMay 2015
- Primary completion6 May 2016
- Study completion16 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448550
- Sponsor's protocol ID
- KP-RRC-CE1
- Acronym
- CALIFORNIA
- Status last verified
- May 2018
- First submitted
- 15 May 2015
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Unfractionated Heparin and Bivalirudin for Percutaneous Coronary Intervention for Stable Angina, Unstable Angina, and Non-ST Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02448550
- Acronym / sponsor ID
- CALIFORNIA / KP-RRC-CE1
- Conditions
- Percutaneous Coronary Intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 6 May 2016 (actual)
- Study completion
- 16 Jun 2016 (actual)
- First posted
- 19 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.
The purpose of this trial is to determine whether bivalirudin is non-inferior to unfractionated heparin in patients with stable angina, unstable angina, or non-ST segment elevation myocardial infarction undergoing percutaneous coronary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bivalirudin | Experimental | Drug: BivalirudinBivalirudin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted. |
| unfractionated heparin | Active comparator | Drug: Unfractionated heparinUnfractionated heparin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing PCI for stable angina, unstable angina, or non-ST segment elevation myocardial infarction.
- Age 18 years or older.
Key exclusion criteria (2 listed)
- Inability to obtain consent
- Emergency cardiac catheterization for ST-segment elevation myocardial infarction.
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 |
|---|---|---|
| Bivalirudin | Drug | bivalirudin |
| Unfractionated heparin | Drug | unfractionated heparin |
Primary outcome
Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints)
Time frame: 30-days
2 secondary outcomes
all cause mortality, myocardial infarction, or unplanned revascularization for ischemia
Time frame: 30-days
Bleeding Academic Research Consortium grade III or V bleeding events
Time frame: 30-days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
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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?
A Phase 3 study testing Bivalirudin and Unfractionated heparin in people with Percutaneous Coronary Intervention, run by Kaiser Permanente 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: stopped early, as of the sponsor's last update on 24 May 2018. 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.
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?
The study was stopped early. Results are not available in the source record.
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?
Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints) (time frame: 30-days). 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 May 2018.