Coronary Arterial Disease (CAD)Phase 4PROMOTENCT06916520
Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention (PROMOTE)
A Phase 4 study testing Prasugrel 5 mg and Dual Antiplatelet (DAPT) Therapy in people with Coronary Arterial Disease (CAD) and Percutaneous Coronary Intervention (PCI), run by J.P.S Henriques at 1 site in Netherlands.
Trial summary
Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent-related and non-stent-related ischemic events after percutaneous coronary intervention (PCI). However, this therapy is also associated with a higher risk of bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
- What is being tested?
- Prasugrel 5 mg and Dual Antiplatelet (DAPT) Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Nov 2025to Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Acute Coronary Syndrome
- Chronic Coronary Syndrome
- Successful PCI
Who cannot join
- Known allergy or contraindication for prasugrel, including Active pathological bleeding Severe liver disease (defined as Child Pugh class C)
- Current indication for oral anticoagulant therapy (OAC)
- Indication for ongoing DAPT (e.g. PCI ≤ 6 months for CCS or ACS ≤ 12 months)
- Pregnancy or breast-feeding women
- Participation in another trial with an investigational drug or device
- Recent or ongoing use of CYP2B6 substrates with a narrow therapeutic window (e.g. cyclophosphamide, efavirenz)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Prof José P.S. Henriques, 020 566 9111, cardiol@amsterdamumc.nl
José P.S. Henriques, MD, PhD
About this study
Official title: Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention
Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent-related and non-stent-related ischemic events after percutaneous coronary intervention (PCI). However, this therapy is also associated with a higher risk of bleeding. Given the advances in stent technology and pharmacology, it may be possible to treat patients undergoing PCI with low dose prasugrel as single antiplatelet therapy, regardless of medical history, age or body weight.
Objective: Assess the feasibility and safety of a single antiplatelet strategy with a reduced dose of prasugrel 5 mg after PCI in acute and chronic coronary syndrome patients (ACS and CCS).
Read more
Study design: Open-label, single-centre, randomized controlled trial.
Study population: Patients undergoing successful PCI due to acute or chronic coronary syndrome.
Intervention: A once-daily reduced dose of 5 mg prasugrel for 6 months in CCS patients and for 12 months in ACS patients, preceded by a loading dose of 60 mg prasugrel after PCI, administered without concomitant use of aspirin.
Main study parameters/endpoints: The primary endpoint is Net Adverse Clinical Events (NACE), a composite of all-cause death, myocardial infarction, definite stent thrombosis, ischemic stroke, clinically relevant non-major bleeding or major bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5.
- Being tested
- Prasugrel 5 mg, Dual Antiplatelet (DAPT) Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prasugrel 5 mgDrug
Prasugrel 5 mg once daily (monotherapy)
Dual Antiplatelet (DAPT) TherapyDrug
Dual antiplatelet therapy according to guidelines
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Prasugrel low-dose monotherapy Receives: Drug: Prasugrel 5 mg |
| Control Arm | Active comparator | Dual antiplatelet therapy Receives: Drug: Dual Antiplatelet (DAPT) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NACE (Net Adverse Clinical Events)
The primary endpoint is NACE, a composite of all-cause mortality, myocardial infarction, definite stent thrombosis, ischemic stroke, major bleeding or clinically relevant non-major bleeding defined as BARC type 2, 3 or 5
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start13 Nov 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- J.P.S Henriques
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, J.P.S Henriques, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916520
- Sponsor's protocol ID
- PROMOTE
- Other IDs
- 2024-520351-24-00
- Acronym
- PROMOTE
- Status last verified
- Mar 2026
- First submitted
- 1 Apr 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06916520
- Acronym / sponsor ID
- PROMOTE / PROMOTE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- J.P.S HenriquesUniversity, hospital or other
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Apr 2025 (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.
Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent-related and non-stent-related ischemic events after percutaneous coronary intervention (PCI). However, this therapy is also associated with a higher risk of bleeding. Given the advances in stent technology and pharmacology, it may be possible to treat patients undergoing PCI with low dose prasugrel as single antiplatelet therapy, regardless of medical history, age or body weight.
Objective: Assess the feasibility and safety of a single antiplatelet strategy with a reduced dose of prasugrel 5 mg after PCI in acute and chronic coronary syndrome patients (ACS and CCS).
Study design: Open-label, single-centre, randomized controlled trial.
Study population: Patients undergoing successful PCI due to acute or chronic coronary syndrome.
Intervention: A once-daily reduced dose of 5 mg prasugrel for 6 months in CCS patients and for 12 months in ACS patients, preceded by a loading dose of 60 mg prasugrel after PCI, administered without concomitant use of aspirin.
Main study parameters/endpoints: The primary endpoint is Net Adverse Clinical Events (NACE), a composite of all-cause death, myocardial infarction, definite stent thrombosis, ischemic stroke, clinically relevant non-major bleeding or major bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: Prasugrel 5 mgPrasugrel low-dose monotherapy |
| Control Arm | Active comparator | Drug: Dual Antiplatelet (DAPT) TherapyDual antiplatelet therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute Coronary Syndrome
- Chronic Coronary Syndrome
- Successful PCI
Key exclusion criteria (6 listed)
- Known allergy or contraindication for prasugrel, including Active pathological bleeding Severe liver disease (defined as Child Pugh class C)
- Current indication for oral anticoagulant therapy (OAC)
- Indication for ongoing DAPT (e.g. PCI ≤ 6 months for CCS or ACS ≤ 12 months)
- Pregnancy or breast-feeding women
- Participation in another trial with an investigational drug or device
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 |
|---|---|---|
| Prasugrel 5 mgPrasugrel 5 mg once daily (monotherapy) | Drug | Intervention Arm |
| Dual Antiplatelet (DAPT) TherapyDual antiplatelet therapy according to guidelines | Drug | Control Arm |
Primary outcome
NACE (Net Adverse Clinical Events)
Time frame: 12 months
The primary endpoint is NACE, a composite of all-cause mortality, myocardial infarction, definite stent thrombosis, ischemic stroke, major bleeding or clinically relevant non-major bleeding defined as BARC type 2, 3 or 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Prasugrel 5 mg and Dual Antiplatelet (DAPT) Therapy in people with Coronary Arterial Disease (CAD) and Percutaneous Coronary Intervention (PCI), run by J.P.S Henriques 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 Mar 2026. 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NACE (Net Adverse Clinical Events) (time frame: 12 months). 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 4 Mar 2026.