Coronary Artery DiseasePhase 2/3BW-ACCORDNCT05657041
Body Weight Adjusted Clopidogrel Treatment in Patients With CORonary Artery Disease
A Phase 2/3 study testing Clopidogrel in people with Coronary Artery Disease and Platelet Reactivity, run by St. Antonius Hospital at 2 sites in Netherlands.
Trial summary
Extreme body weights (BW) or body mass index (BMI) affect the pharmacokinetics of antithrombotic drugs and consequently may affect cardiovascular risk during treatment. The goal of this clinical trial is to establish if clopidogrel treatment can be optimized in patients with a low or high BW compared to patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Platelet Reactivity
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesNetherlands
- Study dates
- 26 Apr 2023to 1 Nov 2024
- Phase
- Phase 2/3
- 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
- Patients, male or female, ≥18 years of age
- Patients treated for CCS with clopidogrel 75mg QD (aspirin 100mg QD).
- Patients must be treated with clopidogrel 75mg for at least one month
- Patients must give consent by means of a signed informed consent
Who cannot join
- Contra-indication for aspirin
- Contra-indication for clopidogrel or prasugrel
- Occurrence of an ischemic event after PCI or ACS (stroke, myocardial infarction, or coronary revascularization)
- Presence of unstable angina complaints.
- Presence of two CYP2C19 Loss-of-function (LOF) alleles (*2 or *3)
- Scheduled for cardiac valve surgery
Show all 12Show fewer
- Indication for chronic oral anticoagulants
- Expected life span of less than one year
- Pregnancy
- Suboptimal stent placement as determined by the cardiologist.
- Patients at increased risk of bleeding with two of the following characteristics: liver cirrhosis with portal hypertension, enhanced bleeding tendency, active malignancy in the past 12 months, thrombocytopenia, major surgery in the past month, spontaneous intracerebral haemorrhage, traumatic intracerebral haemorrhage in the past 12 months, major bleeding requiring hospitalisation or blood transfusion in the past month, ischaemic CVA in the past 5 months.
- Known with established stent thrombosis
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Not yet recruiting
StAntoniusH
Nieuwegein, Utrecht, 3435CM
Wout van den Broek, MD, 088 320 13 37, w.van.den.broek2@antoniusziekenhuis.nl
Jur ten Berg, MD, PhD
- Recruiting
St. Antonius Hospital
Nieuwegein
Jurrien ten berg, 088 320 09 00, j.ten.berg@antoniusziekenhuis.nl
About this study
Official title: Body Weight Adjusted Clopidogrel Treatment in Patients With Coronary Artery Disease
Extreme body weights (BW) or body mass index (BMI) affect the pharmacokinetics of antithrombotic drugs and consequently may affect cardiovascular risk during treatment. The goal of this clinical trial is to establish if clopidogrel treatment can be optimized in patients with a low or high BW compared to patients with a normal BW by adjusting the dosage of clopidogrel and evaluating platelet reactivity.
Participants are stratified into three groups based on their BW (Low BW: BW <60kg; normal BW: 60-100kg; High BW: >100 kg)
Read more
Clopidogrel dosage will then be adjusted to the BW, as follows:
- Low BW: >10 days clopidogrel 50mg 1dd1, followed by >10 days clopidogrel 25mg 1dd1.
- Normal BW: Clopidogrel 75mg 1dd1.
- High BW: >10 days clopidogrel 150mg 1dd1 followed by >10 days prasugrel 10mg 1dd1.
The primary endpoint of the study is P2Y12 Reaction Units (PRU) and platelet inhibition measured using the VerifyNow measured before starting new treatment regimen (at the end of 10 days of treatment).
Read the detailed description
Patients with a high BMI/BW have a higher cardiovascular risk and patients with a low BMI/BW seem to have a higher bleeding risk. A high BMI/BW affects the efficacy of clopidogrel. It is not yet known if this clopidogrel efficacy is altered in patients with a low BMI/BW and whether BW-adjusted treatment can optimise this efficacy. We hypothesize that a personalised treatment will eventually lead to a more optimal effect of clopidogrel, optimizing the balance between bleeding and thrombotic risk. This could benefit therapy compliance.
Primary Objective:
To determine if clopidogrel treatment can be optimized in patients with a low or high BW compared to patients with a normal BW by adjusting the dosage of clopidogrel and evaluating platelet reactivity measured using the VerifyNow.
Secondary Objective(s):
To determine if the CYP2C19 genotype has additional effect on the platelet reactivity in the different treatment groups.
This is a non-randomized single centre, prospective, experimental study in patients with CCS treated with clopidogrel 75mg (and aspirin). This study is designed to be pragmatic and is intended to be hypothesis generating. Patients have to be treated with clopidogrel for at least one month without the occurrence of a major bleeding event, an ischemic event (stroke, myocardial infarction, or coronary revascularization) and have to be free of angina complaints.
Participants are stratified into three groups based on their BW (Low BW: BW <60kg; normal BW: 60-100kg; High BW: >100 kg)
Clopidogrel dosage will then be adjusted to the BW, as follows:
- Low BW: >10 days clopidogrel 50mg 1dd1, followed by >10 days clopidogrel 25mg 1dd1.
- Normal BW: Clopidogrel 75mg 1dd1.
- High BW: >10 days clopidogrel 150mg 1dd1 followed by >10 days prasugrel 10mg 1dd1.
- Conditions
- Coronary Artery Disease, Platelet Reactivity
- Being tested
- Clopidogrel
- Keywords
- Antithrombotic Drugs, Pharmacodynamics, Clopidogrel
- 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.
ClopidogrelDrug
Also called Prasugrel, Body weight adjusted
Body weight adjusted clopidogrel dosing
| Study group | Role | What they receive |
|---|---|---|
| Group 1: body weight <60kg | Experimental | Treatment with clopidogrel 50mg once daily for a minimum of 10 days (max. 14 days), followed by a minimum of 10 days treatment with clopidogrel 25mg once daily (max 14 days). Receives: Drug: Clopidogrel |
| Group 2: body weight 60-100kg | No intervention | Treatment with clopidogrel 75mg once daily |
| Group 3: body weight >100kg | Experimental | Treatment with clopidogrel 150mg once daily for a minimum of 10 days (max. 14 days), followed by a minimum of 10 days treatment with prasugrel 10mg once daily (max 14 days). Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity
Change in P2Y12 Reaction Units (PRU) measured using the VerifyNow
Measured: Baseline and 10 days after dose alteration
High on-treatment platelet reactivity (HTPR)
Number of participants with high on-treatment platelet reactivity (HTPR) defined by a PRU >208
Measured: Baseline
High on-treatment platelet reactivity (HTPR)
Number of participants with high on-treatment platelet reactivity (HTPR) defined by a PRU >208
Measured: 10 days
High on-treatment platelet reactivity (HTPR)
umber of participants with high on-treatment platelet reactivity (HTPR) defined by a PRU >208
Measured: 20 days
Secondary outcomes (5)
Bleeding complications
Number of participants with major or clinically relevant bleeding complications according to the Bleeding Academic Research Consortium Definition for Bleeding (BARC) classification.
Measured: 30 days
Myocardial infarction
Number of participants with myocardial infarction as defined by the 4th Universal Definition of Myocardial Infarction
Measured: 30 days
Stroke
Number of participants with stroke as defined by VARC definitions
Measured: 30 days
Stent thrombosis
Number of participants with stent thrombosis as defined by ARC
Measured: 30 days
All-cause death
Number of participants with all-cause death as defined by ARC
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 posted20 Dec 2022
- Study start26 Apr 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Nov 2024 (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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective, experimental study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius hospital Onderzoeksfonds, ACE Pharmaceuticals BV, Allgen pharmaceuticals
- Responsible party
- Principal investigator, Jurriën M. ten Berg, MD, PhD, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657041
- Sponsor's protocol ID
- NL81095.100.22
- Acronym
- BW-ACCORD
- Status last verified
- May 2023
- First submitted
- 18 Nov 2022
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- 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 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Weight Adjusted Clopidogrel Treatment in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05657041
- Acronym / sponsor ID
- BW-ACCORD / NL81095.100.22
- Conditions
- Coronary Artery Disease, Platelet Reactivity
- Keywords
- Antithrombotic Drugs, Pharmacodynamics, Clopidogrel
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- St. Antonius hospital Onderzoeksfonds, ACE Pharmaceuticals BV, Allgen pharmaceuticals
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 20 Dec 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.
Extreme body weights (BW) or body mass index (BMI) affect the pharmacokinetics of antithrombotic drugs and consequently may affect cardiovascular risk during treatment. The goal of this clinical trial is to establish if clopidogrel treatment can be optimized in patients with a low or high BW compared to patients with a normal BW by adjusting the dosage of clopidogrel and evaluating platelet reactivity.
Participants are stratified into three groups based on their BW (Low BW: BW <60kg; normal BW: 60-100kg; High BW: >100 kg)
Clopidogrel dosage will then be adjusted to the BW, as follows:
- Low BW: >10 days clopidogrel 50mg 1dd1, followed by >10 days clopidogrel 25mg 1dd1.
- Normal BW: Clopidogrel 75mg 1dd1.
- High BW: >10 days clopidogrel 150mg 1dd1 followed by >10 days prasugrel 10mg 1dd1.
The primary endpoint of the study is P2Y12 Reaction Units (PRU) and platelet inhibition measured using the VerifyNow measured before starting new treatment regimen (at the end of 10 days of treatment).
Detailed description
Patients with a high BMI/BW have a higher cardiovascular risk and patients with a low BMI/BW seem to have a higher bleeding risk. A high BMI/BW affects the efficacy of clopidogrel. It is not yet known if this clopidogrel efficacy is altered in patients with a low BMI/BW and whether BW-adjusted treatment can optimise this efficacy. We hypothesize that a personalised treatment will eventually lead to a more optimal effect of clopidogrel, optimizing the balance between bleeding and thrombotic risk. This could benefit therapy compliance.
Primary Objective:
To determine if clopidogrel treatment can be optimized in patients with a low or high BW compared to patients with a normal BW by adjusting the dosage of clopidogrel and evaluating platelet reactivity measured using the VerifyNow.
Secondary Objective(s):
To determine if the CYP2C19 genotype has additional effect on the platelet reactivity in the different treatment groups.
This is a non-randomized single centre, prospective, experimental study in patients with CCS treated with clopidogrel 75mg (and aspirin). This study is designed to be pragmatic and is intended to be hypothesis generating. Patients have to be treated with clopidogrel for at least one month without the occurrence of a major bleeding event, an ischemic event (stroke, myocardial infarction, or coronary revascularization) and have to be free of angina complaints.
Participants are stratified into three groups based on their BW (Low BW: BW <60kg; normal BW: 60-100kg; High BW: >100 kg)
Clopidogrel dosage will then be adjusted to the BW, as follows:
- Low BW: >10 days clopidogrel 50mg 1dd1, followed by >10 days clopidogrel 25mg 1dd1.
- Normal BW: Clopidogrel 75mg 1dd1.
- High BW: >10 days clopidogrel 150mg 1dd1 followed by >10 days prasugrel 10mg 1dd1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- prospective, experimental study
| Arm | Type | Receives |
|---|---|---|
| Group 1: body weight <60kg | Experimental | Drug: ClopidogrelTreatment with clopidogrel 50mg once daily for a minimum of 10 days (max. 14 days), followed by a minimum of 10 days treatment with clopidogrel 25mg once daily (max 14 days). |
| Group 2: body weight 60-100kg | No intervention | –Treatment with clopidogrel 75mg once daily |
| Group 3: body weight >100kg | Experimental | Drug: ClopidogrelTreatment with clopidogrel 150mg once daily for a minimum of 10 days (max. 14 days), followed by a minimum of 10 days treatment with prasugrel 10mg once daily (max 14 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients, male or female, ≥18 years of age
- Patients treated for CCS with clopidogrel 75mg QD (aspirin 100mg QD).
- Patients must be treated with clopidogrel 75mg for at least one month
- Patients must give consent by means of a signed informed consent
Key exclusion criteria (12 listed)
- Contra-indication for aspirin
- Contra-indication for clopidogrel or prasugrel
- Occurrence of an ischemic event after PCI or ACS (stroke, myocardial infarction, or coronary revascularization)
- Presence of unstable angina complaints.
- Presence of two CYP2C19 Loss-of-function (LOF) alleles (*2 or *3)
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 |
|---|---|---|
| ClopidogrelAlso: Prasugrel, Body weight adjustedBody weight adjusted clopidogrel dosing | Drug | Group 1: body weight <60kg, Group 3: body weight >100kg |
Primary outcome
Platelet reactivity
Time frame: Baseline and 10 days after dose alteration
Change in P2Y12 Reaction Units (PRU) measured using the VerifyNow
High on-treatment platelet reactivity (HTPR)
Time frame: Baseline
Number of participants with high on-treatment platelet reactivity (HTPR) defined by a PRU >208
High on-treatment platelet reactivity (HTPR)
Time frame: 10 days
Number of participants with high on-treatment platelet reactivity (HTPR) defined by a PRU >208
High on-treatment platelet reactivity (HTPR)
Time frame: 20 days
umber of participants with high on-treatment platelet reactivity (HTPR) defined by a PRU >208
5 secondary outcomes
Bleeding complications
Time frame: 30 days
Myocardial infarction
Time frame: 30 days
Stroke
Time frame: 30 days
Stent thrombosis
Time frame: 30 days
All-cause death
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Clopidogrel in people with Coronary Artery Disease and Platelet Reactivity, run by St. Antonius Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 2 Jun 2023. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
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?
Platelet reactivity (time frame: Baseline and 10 days after dose alteration). The study lists 4 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 2 Jun 2023.