STEMI - ST Elevation Myocardial InfarctionNCT04138641
Dutch Cangrelor Registry
An observational study of STEMI - ST Elevation Myocardial Infarction and NSTEMI - Non-ST Segment Elevation MI, run by Isala at 1 site in Netherlands.
Trial summary
Cangrelor is a fast and directly acting platelet aggregation inhibitor. It is potentially indicated for several types of patients who are undergoing PCI. A nationwide cangrelor registry has up until now not been performed and with the introduction of cangrelor in the Netherlands its efficacy and safety will be… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, Coronary Artery Disease
- What is being tested?
- Cangrelor
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Dec 2019to 24 Jul 2020
- How long will I take part?
- 30 Days
- 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 to 110 years
- All sexes
- Adult, Older adult
Study population: Patients undergoing (primary) PCI
Who may be able to join
- Age ≥18 years
- One of the following criteria:
- Patients naïve for P2Y12 inhibition undergoing PCI
- Patients with suboptimal P2Y12 inhibition undergoing PCI (patients who vomited after P2Y12 loading, out of hospital cardiac arrest (OHCA) patients with restoration of spontaneous circulation (ROSC), patients loaded with P2Y12 inhibitors though platelet inhibition still insufficient (<2 hours after oral loading dose)
- (N)STEMI patients loaded with P2Y12 inhibitors with large thrombus burden (thrombus grade 4 or 5) on initial coronary angiography (CAG) and undergoing primary PCI with expected insufficient P2Y12 inhibition
Who cannot join
- Patients on current/chronic treatment with P2Y12 inhibitors
- Patients (pre) treated with a GPI
- Patients with recent major bleeding complications or contraindication to dual antiplatelet therapy:
- hypersensitivity or allergy to and known contra-indication for aspirin, clopidogrel, ticagrelor or cangrelor
- history of major clinical bleeding or known coagulopathy
- active bleeding
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- history of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
- known severe liver dysfunction
- Patients that received any organ transplant or are on a waiting list for any organ transplant
- Patients undergoing dialysis
- Pregnant or lactating female
- Patients currently participating in another investigational drug or device study
Trial locations and contacts
1 site in 1 country.
About this study
Cangrelor is a fast and directly acting platelet aggregation inhibitor. It is potentially indicated for several types of patients who are undergoing PCI. A nationwide cangrelor registry has up until now not been performed and with the introduction of cangrelor in the Netherlands its efficacy and safety will be determined.
- Conditions
- STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, Coronary Artery Disease
- Being tested
- Cangrelor
- Medical subject headings
- ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CangrelorDrug
Cangrelor intravenous
What is being measured
The primary outcome is the main question the study is designed to answer.
NACE
The primary efficacy and safety endpoint is 48 hours Net Adverse Clinical Events (NACE), which is a composite endpoint of all-cause death (including cardiac death), recurrent myocardial infarction, target vessel revascularization, stroke, definite or probable stent thrombosis and bleeding (BARC type 2-5).
Measured: 48 hours
Secondary outcomes (4)
NACE 30 days
Net Adverse Clinical Events (NACE), which is a composite endpoint of all-cause death (including cardiac death), recurrent myocardial infarction, target vessel revascularization, stroke, definite or probable stent thrombosis and bleeding (BARC type 2-5).
Measured: 30 days
All individual endpoints in-hospital
All individual endpoints in-hospital
Measured: In-hospital, mostly up to 72 hours.
All individual endpoints at 30-days
All individual endpoints at 30-days
Measured: 30 days
TIMI 3 flow post PCI based on angiographic results
TIMI 3 flow post PCI
Measured: post-PCI, mostly up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start17 Dec 2019
- Primary completion24 Jul 2020
- Study completion24 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A.H. Tavenier, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138641
- Sponsor's protocol ID
- Dutch Cangelor registry
- Status last verified
- Jul 2020
- First submitted
- 17 Oct 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dutch Cangrelor Registry
- ClinicalTrials.gov ID
- NCT04138641
- Acronym / sponsor ID
- Dutch Cangelor registry
- Conditions
- STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 24 Jul 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 24 Oct 2019 (actual)
- 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.
Cangrelor is a fast and directly acting platelet aggregation inhibitor. It is potentially indicated for several types of patients who are undergoing PCI. A nationwide cangrelor registry has up until now not been performed and with the introduction of cangrelor in the Netherlands its efficacy and safety will be determined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing (primary) PCI
Key inclusion criteria (5 listed)
- Age ≥18 years
- One of the following criteria:
- Patients naïve for P2Y12 inhibition undergoing PCI
- Patients with suboptimal P2Y12 inhibition undergoing PCI (patients who vomited after P2Y12 loading, out of hospital cardiac arrest (OHCA) patients with restoration of spontaneous circulation (ROSC), patients loaded with P2Y12 inhibitors though platelet inhibition still insufficient (<2 hours after oral loading dose)
- (N)STEMI patients loaded with P2Y12 inhibitors with large thrombus burden (thrombus grade 4 or 5) on initial coronary angiography (CAG) and undergoing primary PCI with expected insufficient P2Y12 inhibition
Key exclusion criteria (12 listed)
- Patients on current/chronic treatment with P2Y12 inhibitors
- Patients (pre) treated with a GPI
- Patients with recent major bleeding complications or contraindication to dual antiplatelet therapy:
- hypersensitivity or allergy to and known contra-indication for aspirin, clopidogrel, ticagrelor or cangrelor
- history of major clinical bleeding or known coagulopathy
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 |
|---|---|---|
| CangrelorCangrelor intravenous | Drug | – |
Primary outcome
NACE
Time frame: 48 hours
The primary efficacy and safety endpoint is 48 hours Net Adverse Clinical Events (NACE), which is a composite endpoint of all-cause death (including cardiac death), recurrent myocardial infarction, target vessel revascularization, stroke, definite or probable stent thrombosis and bleeding (BARC type 2-5).
4 secondary outcomes
NACE 30 days
Time frame: 30 days
All individual endpoints in-hospital
Time frame: In-hospital, mostly up to 72 hours.
All individual endpoints at 30-days
Time frame: 30 days
TIMI 3 flow post PCI based on angiographic results
Time frame: post-PCI, mostly up to 1 hour
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 28 Jul 2020.
- Individual participant dataSharing planned: No
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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 STEMI - ST Elevation Myocardial Infarction and NSTEMI - Non-ST Segment Elevation MI, run by Isala at 1 site in Netherlands.
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 5 inclusion and 12 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 28 Jul 2020. 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 Netherlands. 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?
NACE (time frame: 48 hours). 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 28 Jul 2020.