Coronary Artery DiseaseDAPT-FOR-REALNCT05559918
Dual-antiplatelet Therapy Strategies for Elective PCI in a Real-world Setting
An observational study of Coronary Artery Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial summary
To assess the safety and efficacy of in-laboratory clopidogrel loading dose administration before ad-hoc PCI versus clopidogrel preloading treatment in patients planned for diagnostic angiography with optional ad-hoc PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 1,462 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Oct 2022to 31 Dec 2025
- How long will I take part?
- 1 Month
- 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: Consecutive patients aged 18 years and older who have been referred for diagnostic CAG due to symptoms suggestive of obstructive coronary artery disease with optional ad-hoc PCI.
Who may be able to join
- Adult men and women aged at least 18 years
- Scheduled for diagnostic CAG due to suspected obstructive coronary artery disease
Who cannot join
- Presence of contra-indications for the use of clopidogrel (hypersensitivity or known allergy to clopidogrel, severe liver insufficiency, resent or active pathological bleeding, patients known to be poor CYP2C19 metabolizers, patients using pharmacological CYP2C19 inhibitors and inducers)
- Patients using clopidogrel for other reasons than the scheduled diagnostic CAG (e.g. due to previous stroke)
- Patients using P2Y12 inhibitors other than clopidogrel (e.g. prasugrel, ticagrelor, cangrelor)
- Patients using VKA (e.g. acenocoumarol, fenprocoumon)
- Patients using DOAC/NOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban)
- Inability to give informed consent (e.g., language barrier)
- Patients who have a documented mentioning of previous denial to any trial participation in the electronic patient dossier
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam Universitair Medisch Centrum (AUMC) - Locatie AMC
Amsterdam, North Holland
Ronak Delewi, MD PhD, r.delewi@amsterdamumc.nl
- Recruiting
Amsterdam Universitair Medisch Centrum (AUMC) - Locatie VUMC
Amsterdam, North Holland
Niels Verouden, MD PhD, c.verouden@amsterdamumc.nl
About this study
To assess the safety and efficacy of in-laboratory clopidogrel loading dose administration before ad-hoc PCI versus clopidogrel preloading treatment in patients planned for diagnostic angiography with optional ad-hoc PCI.
- Conditions
- Coronary Artery Disease
- Keywords
- Pretreatment, Diagnostic angiography, ad-hoc PCI
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Preloading with clopidogrel | Not described | |
| In-hospital loading with clopidogrel | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net adverse clinical events (NACE)
The incidence rate of NACE (the composite of the clinical events all-cause death, myocardial infarction, definite/probable stent thrombosis, stroke and BARC type 2, -3 or -5 bleeding) wil be compared between groups at 30 days
Measured: 30 days
Secondary outcomes (7)
Bleeding (classified as BARC type 2, -3 and -5 bleeding)
The incidence rate of bleeding (classified as BARC type 2, -3 and -5 bleeding) will be compared between groups
Measured: In-hospital, at 30 days
Patient oriented clinical events (POCE)
The incidence rate of POCE (the composite of clinical events all-cause death, stroke, myocardial infarction, and repeat revascularization) will be compared between groups
Measured: In-hospital, at 30 days
All-cause mortality
The incidence rate of all-cause mortality will be compared between groups
Measured: In-hospital, at 30 days
Myocardial infarction
The incidence rate of myocardial infarction will be compared between groups
Measured: In-hospital, at 30 days
Stent thrombosis (definite/probable)
The incidence rate of stent thrombosis (definite and probable) will be compared between groups
Measured: In-hospital, at 30 days
Stroke
The incidence rate of stroke will be compared between groups
Measured: In-hospital, at 30 days
Repeat revascularisation
The incidence rate of repeat revascularisation will be compared between groups
Measured: In-hospital, at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Oct 2022
- Primary completion30 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,462 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronak Delewi, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Ronak Delewi, MD, PhD, Principal investigator, Amsterdam University Medical Center, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559918
- Sponsor's protocol ID
- AUMC25485
- Acronym
- DAPT-FOR-REAL
- Status last verified
- Apr 2024
- First submitted
- 21 Sep 2022
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-antiplatelet Therapy Strategies for Elective PCI in a Real-world Setting
- ClinicalTrials.gov ID
- NCT05559918
- Acronym / sponsor ID
- DAPT-FOR-REAL / AUMC25485
- Conditions
- Coronary Artery Disease
- Keywords
- Pretreatment, Diagnostic angiography, ad-hoc PCI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,462 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Sep 2022 (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.
To assess the safety and efficacy of in-laboratory clopidogrel loading dose administration before ad-hoc PCI versus clopidogrel preloading treatment in patients planned for diagnostic angiography with optional ad-hoc PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preloading with clopidogrel | – | – |
| In-hospital loading with clopidogrel | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients aged 18 years and older who have been referred for diagnostic CAG due to symptoms suggestive of obstructive coronary artery disease with optional ad-hoc PCI.
Key inclusion criteria (2 listed)
- Adult men and women aged at least 18 years
- Scheduled for diagnostic CAG due to suspected obstructive coronary artery disease
Key exclusion criteria (7 listed)
- Presence of contra-indications for the use of clopidogrel (hypersensitivity or known allergy to clopidogrel, severe liver insufficiency, resent or active pathological bleeding, patients known to be poor CYP2C19 metabolizers, patients using pharmacological CYP2C19 inhibitors and inducers)
- Patients using clopidogrel for other reasons than the scheduled diagnostic CAG (e.g. due to previous stroke)
- Patients using P2Y12 inhibitors other than clopidogrel (e.g. prasugrel, ticagrelor, cangrelor)
- Patients using VKA (e.g. acenocoumarol, fenprocoumon)
- Patients using DOAC/NOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban)
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
Net adverse clinical events (NACE)
Time frame: 30 days
The incidence rate of NACE (the composite of the clinical events all-cause death, myocardial infarction, definite/probable stent thrombosis, stroke and BARC type 2, -3 or -5 bleeding) wil be compared between groups at 30 days
7 secondary outcomes
Bleeding (classified as BARC type 2, -3 and -5 bleeding)
Time frame: In-hospital, at 30 days
Patient oriented clinical events (POCE)
Time frame: In-hospital, at 30 days
All-cause mortality
Time frame: In-hospital, at 30 days
Myocardial infarction
Time frame: In-hospital, at 30 days
Stent thrombosis (definite/probable)
Time frame: In-hospital, at 30 days
Stroke
Time frame: In-hospital, at 30 days
Repeat revascularisation
Time frame: In-hospital, at 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- 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.
Ronak Delewi, MD, PhD principal investigator
Amsterdam University Medical Center, location AMC
2 sites 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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronak Delewi, MD, PhD (+31(0)20 566 9111, r.delewi@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net adverse clinical events (NACE) (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 Apr 2024.