Coronary ArteriosclerosesPhase 4IDEAL-PCI extNCT02974777
The IDEAL-PCI Extended Registry
A Phase 4 study testing DAPT reduction, DAPT on-target and DAPT intensification in people with Coronary Arterioscleroses and Platelet Dysfunction Due to Drugs, run by Kaiser Franz Josef Hospital at 1 site in Austria.
Trial summary
The purpose of this study is to determine the efficacy and safety of a routine individualized antiplatelet therapy after coronary stent implantation by evaluating "on-treatment" platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Arterioscleroses, Platelet Dysfunction Due to Drugs
- What is being tested?
- DAPT reduction, DAPT on-target and DAPT intensification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Start not givento Jan 2017
- Phase
- Phase 4
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all consecutive PCI patients
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Extended Registry
The purpose of this study is to determine the efficacy and safety of a routine individualized antiplatelet therapy after coronary stent implantation by evaluating "on-treatment" platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).
IDEAL-PCI Extended is the continuation of the IDEAL-PCI registry with additional focus on bleeding events and net clinical benefit
Read the detailed description
Determination of platelet reactivity in patients with percutaneous coronary Intervention as described in the IDEAL-PCI registry.
In the IDEAL-PCI Extended Registry an additional deescalation arm with reduction of the standard dual antiplatelet therapy (DAPT) dosis in case of low platelet reactivity to P2Y12 Inhibition or Aspirin with or without bleeding is implemented.
- Being tested
- DAPT reduction, DAPT on-target, DAPT intensification
- 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.
DAPT reductionDrug
Reduction of standard dose DAPT due to low platelet reactivity
DAPT on-targetDrug
Standard DAPT within the therapeutic window of platelet reactivity
DAPT intensificationDrug
Intensification of standard dose DAPT due to high platelet reactivity
| Study group | Role | What they receive |
|---|---|---|
| Bleeding prevention group | Active comparator | Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor Receives: Drug: DAPT reduction; Drug: DAPT on-target |
| Ischemia prevention group | Active comparator | Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor Receives: Drug: DAPT on-target; Drug: DAPT intensification |
What is being measured
The primary outcome is the main question the study is designed to answer.
stent thrombosis
stent thrombosis by any Academic Research Consortium (ARC) definition
Measured: 1 year
bleeding
bleeding type 1-3 and 5 by Bleeding Academic Research Consortium (BARC) definition
Measured: 1 year
Secondary outcomes (1)
Major adverse cardiac and cerebrovascular Events (MACCE)
death, cardiovascular death, myocardial infarction, stroke, ischemia driven 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 posted28 Nov 2016 (estimated)
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: not started due to regulatory reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Franz Josef Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Guenter Christ, Kaiser Franz Josef Hospital
- Investigators
- Guenter Christ, MD, Principal investigator, Kaiser Franz Josef Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974777
- Sponsor's protocol ID
- IDEAL-PCI v.2
- Acronym
- IDEAL-PCI ext
- Status last verified
- Jan 2018
- First submitted
- 23 Nov 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Extended Registry
- ClinicalTrials.gov ID
- NCT02974777
- Acronym / sponsor ID
- IDEAL-PCI ext / IDEAL-PCI v.2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not started due to regulatory reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kaiser Franz Josef HospitalUniversity, hospital or other
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 28 Nov 2016 (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 study is to determine the efficacy and safety of a routine individualized antiplatelet therapy after coronary stent implantation by evaluating "on-treatment" platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).
IDEAL-PCI Extended is the continuation of the IDEAL-PCI registry with additional focus on bleeding events and net clinical benefit
Detailed description
Determination of platelet reactivity in patients with percutaneous coronary Intervention as described in the IDEAL-PCI registry.
In the IDEAL-PCI Extended Registry an additional deescalation arm with reduction of the standard dual antiplatelet therapy (DAPT) dosis in case of low platelet reactivity to P2Y12 Inhibition or Aspirin with or without bleeding is implemented.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bleeding prevention group | Active comparator | Drug: DAPT reduction, Drug: DAPT on-targetPatients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor |
| Ischemia prevention group | Active comparator | Drug: DAPT on-target, Drug: DAPT intensificationPatients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all consecutive PCI patients
Key exclusion criteria (1 listed)
- pregnancy
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 |
|---|---|---|
| DAPT reductionReduction of standard dose DAPT due to low platelet reactivity | Drug | Bleeding prevention group |
| DAPT on-targetStandard DAPT within the therapeutic window of platelet reactivity | Drug | Bleeding prevention group, Ischemia prevention group |
| DAPT intensificationIntensification of standard dose DAPT due to high platelet reactivity | Drug | Ischemia prevention group |
Primary outcome
stent thrombosis
Time frame: 1 year
stent thrombosis by any Academic Research Consortium (ARC) definition
bleeding
Time frame: 1 year
bleeding type 1-3 and 5 by Bleeding Academic Research Consortium (BARC) definition
1 secondary outcome
Major adverse cardiac and cerebrovascular Events (MACCE)
Time frame: 1 year
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 26 Jan 2018.
- IDEAL-PCI RegistryLink provided by the sponsor.
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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.
Guenter Christ, MD principal investigator
Kaiser Franz Josef Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DAPT reduction, DAPT on-target and DAPT intensification in people with Coronary Arterioscleroses and Platelet Dysfunction Due to Drugs, run by Kaiser Franz Josef Hospital at 1 site in Austria.
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 1 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 26 Jan 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 Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
stent thrombosis (time frame: 1 year). The study lists 2 primary outcomes in all. 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 26 Jan 2018.