Dual Antiplatelet TherapyPhase 3DESC-HBRNCT05903976
De-escalating Antiplatelet Therapy to Assess Platelet Reactivity and Outcomes in High Bleeding Risk Patients With Recent ACS
A Phase 3 study testing P2Y12 inhibitor de-escalation in people with Dual Antiplatelet Therapy and Acute Coronary Syndrome, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" at 2 sites in Italy.
Trial summary
High bleeding risk (HBR) patients, comprising up to 50% of those presenting with acute coronary syndrome (ACS), are a high-risk group that is increasing in size due to an aging population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dual Antiplatelet Therapy, Acute Coronary Syndrome, Coronary Artery Disease
- What is being tested?
- P2Y12 inhibitor de-escalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- 12 Jun 2023to 30 Oct 2025
- Phase
- Phase 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
Participants fulfilling all the following inclusion criteria are eligible for the study:
- Informed Consent signed and dated.
- Patients deemed at HBR according to standard definitions (i.e. PRECISE-DAPT ≥25 or HBR-ARC with at least 1 major or 2 minor criteria).
- Treated with PCI due to a recent ACS (i.e. unstable angina, non-ST segment elevated myocardial infarction or ST segment elevated myocardial infarction) 30 ±7 days earlier.
- Treated with DAPT with full-dose potent P2Y12 inhibitors (e.g. prasugrel 10mg or ticagrelor 90mg bid) according to international guidelines recommendations.
The presence of anyone of the following exclusion criteria will lead to exclusion of the participant:
- Age < 18 years
- Known intolerance, hypersensitivity or contraindication (including active bleeding) to aspirin, clopidogrel, prasugrel, ticagrelor or to any of the excipients
- Indication to oral anticoagulation
- Indication to prolonged treatment with full-dose potent P2Y12 inhibitors (e.g. previous stent thrombosis, stenting of last remaining vessel, stent with indication for longer-term DAPT, perceived very high coronary ischemic risk)
- Any planned major surgery or interventional procedure requiring treatment modification
- Prior transient ischemic attack, ischemic or haemorrhagic stroke
- Severe hepatic insufficiency (Child-Pugh class C)
- Ongoing therapy with strong CYP3A inducers or strong CYP3A inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir etc.)
- Women who are pregnant, breast feeding or of childbearing potential (i.e. fertile, following menarche and who are not surgically sterile, including hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or post-menopausal defined as no menses for 12 months without an alternative medical cause); Participation in another study with investigational drug within the 30 days, or 5 half-lives of the study drug whichever is longer, preceding and during the present study
- Enrolment of the investigator, his/her family members, employees
- Inability to follow the procedures of the study (language problems, mental disorders, dementia) or comorbidities associated with less than 12 months-life expectation (active malignancies drug or alcohol abuse, etc.) or other conditions that might result in protocol non-compliance.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Gaetano Martino
Messina, 98125
Francesco Costa, MD, PhD
Francesco Costa, MD, PhD
- Not yet recruiting
Ospedale degli Infermi
Rivoli, 10098
Greca Zanda, MD
Giorgio Quadri, MD
About this study
Official title: De-Escalation of Antiplatelet Therapy to Evaluate Platelet Reactivity and Clinical Outcomes After Coronary Stenting in Patients at High Bleeding Risk and Recent Acute Coronary Syndrome: DESC-HBR Trial
High bleeding risk (HBR) patients, comprising up to 50% of those presenting with acute coronary syndrome (ACS), are a high-risk group that is increasing in size due to an aging population. The optimal selection of the potency and duration of antiplatelet therapy to reduce the risk of recurrent ischemic and bleeding events in HBR patients is still a matter of debate. Multiple strategies to reduce bleeding during secondary prevention, such as reducing the duration of dual antiplatelet therapy, using single antiplatelet therapy with a P2Y12 inhibitor, or de-escalating to a lower potency or lower-dose P2Y12 inhibitor, have been proposed. De-escalation to a lower potency or lower-dose P2Y12 inhibitor is particularly attractive because it maintains efficient pharmacological inhibition of multiple platelet pathways while potentially reducing bleeding through less aggressive activity. Yet, there has been no study comparing the effects of different de-escalation strategies with the standard potent P2Y12 inhibitors in HBR patients. The aim of the DESC-HBR study is to assess the impact of de-escalating P2Y12 inhibitor to clopidogrel 75mg, prasugrel 5mg or ticagrelor 60mg bid in HBR patients, in comparison with full-dose potent P2Y12 inhibitors, on the proportion of patients with optimal platelet reactivity (OPR). Secondary objectives involve exploring the effect of de-escalation on clinical events and patients' quality of life.
Read the detailed description
The aim of the DESC-HBR trial is to compare the impact of de-escalating P2Y12 inhibitor to clopidogrel 75mg, prasugrel 5mg or ticagrelor 60mg bid, with full-dose potent P2Y12 inhibitors, on the proportion of patients with optimal platelet reactivity (OPR). The secondary objective is to explore the effect of de-escalating P2Y12 inhibitor therapy on clinical events and patients' quality of life. The primary outcome is the proportion of patients in the OPR range measured through the VerifyNow system at peak level after drug maintenance dose (MD) at 14±2 days. OPR is defined as a platelet reactive unit (PRU) between 85 and 208 reactivity units based on international consensus. A key secondary outcome will be major, minor and nuisance bleeding according to the bleeding academic research consortium (BARC) definition up to 5 months. Secondary pharmacodynamic outcomes include platelet reactivity with the VerifyNow and T-TAS system at different timepoints (baseline, 2h after first dose, through levels before MD and peak levels after MD at 14±2 days). Further pharmacodynamic assessment at 1 and 2 weeks after P2Y12 inhibitor discontinuation will be performed in the subset of patients discontinuing P2Y12 inhibitor at study conclusion or in case of P2Y12 discontinuation at anytime during the study.Other secondary endpoints will be explored including all-cause death, major adverse cardiac and cerebrovascular events (MACCE), a composite of cardiac death, myocardial infarction (MI), target vessel revascularization (TVR) and stroke, net adverse clinical events (NACE), a composite of MACCE and BARC 2-5 bleeding, and each individual endpoint singularly appraised. Quality of life will be evaluated with health mobility and performance scales (i.e. EQ-5D-5L, SF-12), perceived stress scale (i.e. PPS).Cost-effectives analysis will be also carried out by inputting direct and indirect costs in relation to outcomes. Study visits are scheduled at baseline,14±2 days, 3 and 5 months after randomization.
- Being tested
- P2Y12 inhibitor de-escalation
- Keywords
- DAPT De-escalation, P2Y12 inhibitors
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P2Y12 inhibitor de-escalationDrug
Comparing, in patients at High Bleeding Risk (HBR) after a recent Acute Coronary Syndrome (ACS), continuation of full-dose potent P2Y12 inhibitor with a P2Y12i de-escalation strategy transitioning to clopidogrel 75mg, prasugrel 5mg or ticagrelor 60mg/bid.
| Study group | Role | What they receive |
|---|---|---|
| CLOPIDOGREL 75 mg qd | Experimental | 50 patients treated with clopidogrel 75mg Receives: Drug: P2Y12 inhibitor de-escalation |
| PRASUGREL 5mg qd | Experimental | 50 patients treated with prasugrel 5mg Receives: Drug: P2Y12 inhibitor de-escalation |
| TICAGRELOR 60mg bid | Experimental | 50 patients treated with ticagrelor 60mg bid Receives: Drug: P2Y12 inhibitor de-escalation |
| Continue Potent P2Y12i Full-Dose | Active comparator | 50 patients in the full-dose potent P2Y12 inhibitor (prasugrel 10 mg or ticagrelor 90 mg bid according to prior prescription) Receives: Drug: P2Y12 inhibitor de-escalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Achieving Optimal Platelet Reactivity (OPR) at peak level following Drug Maintenance Dose (MD) Using the VerifyNow System
The incidence of optimal platelet reactivity (OPR) measured by means of the VerifyNow system. OPR will be defined as a PRU between 85 and 208 reactivity units according to international expert consensus.
Measured: 2 hours after drug MD at 14±2 days from study inclusion
Secondary outcomes (6)
Incidence of Bleeding Events According to Multiple Bleeding Definitions
The incidence of nuisance, minor or major bleeding according to the BARC definition (BARC 1-5).
Measured: 5 Months after enrollment
Platelet reactive units (PRU) at VerifyNow system
Platelet reactive units (PRU) measurement at VerifyNow system
Measured: baseline, 2 hours after the first treatment administration and before MD at 14±2 days from study inclusion
Proportion of high platelet reactivity (HPR) and the proportion of low platelet reactivity (LPR) measured through the VerifyNow system
The proportion of high platelet reactivity (HPR) defined as PRU > 208, and the proportion of low platelet reactivity (LPR), defined as PRU < 85, measured through the VerifyNow system before first randomized treatment administration (baseline), 2 hours after the first randomized treatment administration, before MD at 14±2 days from study inclusion and at 2 hours after drug MD administration at 14±2 days from study inclusion. PRU at 1 and 2 weeks after P2Y12 inhibitor discontinuation study in patients permanently ceasing treatment.
Measured: baseline, 2 hours after the first treatment administration, before MD at 14±2 days from study inclusion and at 2 hours after drug MD administration at 14±2 days
Platelet-derived thrombogenicity at Total Thrombus Formation (T-TAS)
Platelet-derived thrombogenicity at Total Thrombus Formation (T-TAS) before first randomized treatment administration (baseline), 2 hours after the first randomized treatment administration, before and after MD at 14±2 days from study inclusion.
Measured: baseline, 2 hours after the first treatment administration, before and after MD at 14±2 days from study inclusion.
Adverse clinical event
Adverse clinical events, assessed at each visit and up to 5 months after randomization. They include: death, cardiac death, non-fatal myocardial infarction, non-fatal stroke, urgent target vessel revascularization, definite/probable stent thrombosis and net adverse clinical events.
Measured: 14±2 days, 3 and 5 months from study inclusion
Cost-effectiveness
Cost-effectives analysis will be carried out by inputting direct and indirect costs in relation to outcomes assessed.
Measured: 5 Months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start12 Jun 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dual Antiplatelet TherapyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Sponsor type
- University, hospital or other
- Collaborators
- Giampiero Vizzari, Giorgio Quadri, Greca Zanda, Ferdinando Varbella, Gianluca Di Bella, Antonio Micari
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903976
- Sponsor's protocol ID
- DESC-HBR
- Acronym
- DESC-HBR
- Status last verified
- Aug 2023
- First submitted
- 26 May 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Costa F, Vizzari G, Zecchino S, Galli M, Montalto C, Carciotto G, Quadri G, Vergallo R, Castriota F, Soraci E, Magliarditi A, Giudice SL, Iuvara G, Munafo A, Giannino F, Pallante F, Franzino M, Teresi L, Piccolo R, Varbella F, Musumeci G, Di Bella G, Ortega-Paz L, Angiolillo DJ, Micari A. De-escalation of antiplatelet therapy to evaluate platelet reactivity and clinical outcomes after coronary stenting in patients at high bleeding risk and recent acute coronary syndrome: Rationale and design of the DESC-HBR trial. Cardiovasc Revasc Med. 2026 Aug 4:S1553-8389(26)00334-9. doi: 10.1016/j.carrev.2026.07.022. Online ahead of print.
PubMed 42567765
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-Escalation of Antiplatelet Therapy to Evaluate Platelet Reactivity and Clinical Outcomes After Coronary Stenting in Patients at High Bleeding Risk and Recent Acute Coronary Syndrome: DESC-HBR Trial
- ClinicalTrials.gov ID
- NCT05903976
- Acronym / sponsor ID
- DESC-HBR / DESC-HBR
- Keywords
- DAPT De-escalation, P2Y12 inhibitors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"University, hospital or other
- Collaborators
- Giampiero Vizzari, Giorgio Quadri, Greca Zanda, Ferdinando Varbella, Gianluca Di Bella, Antonio Micari
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 15 Jun 2023 (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.
High bleeding risk (HBR) patients, comprising up to 50% of those presenting with acute coronary syndrome (ACS), are a high-risk group that is increasing in size due to an aging population. The optimal selection of the potency and duration of antiplatelet therapy to reduce the risk of recurrent ischemic and bleeding events in HBR patients is still a matter of debate. Multiple strategies to reduce bleeding during secondary prevention, such as reducing the duration of dual antiplatelet therapy, using single antiplatelet therapy with a P2Y12 inhibitor, or de-escalating to a lower potency or lower-dose P2Y12 inhibitor, have been proposed. De-escalation to a lower potency or lower-dose P2Y12 inhibitor is particularly attractive because it maintains efficient pharmacological inhibition of multiple platelet pathways while potentially reducing bleeding through less aggressive activity. Yet, there has been no study comparing the effects of different de-escalation strategies with the standard potent P2Y12 inhibitors in HBR patients. The aim of the DESC-HBR study is to assess the impact of de-escalating P2Y12 inhibitor to clopidogrel 75mg, prasugrel 5mg or ticagrelor 60mg bid in HBR patients, in comparison with full-dose potent P2Y12 inhibitors, on the proportion of patients with optimal platelet reactivity (OPR). Secondary objectives involve exploring the effect of de-escalation on clinical events and patients' quality of life.
Detailed description
The aim of the DESC-HBR trial is to compare the impact of de-escalating P2Y12 inhibitor to clopidogrel 75mg, prasugrel 5mg or ticagrelor 60mg bid, with full-dose potent P2Y12 inhibitors, on the proportion of patients with optimal platelet reactivity (OPR). The secondary objective is to explore the effect of de-escalating P2Y12 inhibitor therapy on clinical events and patients' quality of life. The primary outcome is the proportion of patients in the OPR range measured through the VerifyNow system at peak level after drug maintenance dose (MD) at 14±2 days. OPR is defined as a platelet reactive unit (PRU) between 85 and 208 reactivity units based on international consensus. A key secondary outcome will be major, minor and nuisance bleeding according to the bleeding academic research consortium (BARC) definition up to 5 months. Secondary pharmacodynamic outcomes include platelet reactivity with the VerifyNow and T-TAS system at different timepoints (baseline, 2h after first dose, through levels before MD and peak levels after MD at 14±2 days). Further pharmacodynamic assessment at 1 and 2 weeks after P2Y12 inhibitor discontinuation will be performed in the subset of patients discontinuing P2Y12 inhibitor at study conclusion or in case of P2Y12 discontinuation at anytime during the study.Other secondary endpoints will be explored including all-cause death, major adverse cardiac and cerebrovascular events (MACCE), a composite of cardiac death, myocardial infarction (MI), target vessel revascularization (TVR) and stroke, net adverse clinical events (NACE), a composite of MACCE and BARC 2-5 bleeding, and each individual endpoint singularly appraised. Quality of life will be evaluated with health mobility and performance scales (i.e. EQ-5D-5L, SF-12), perceived stress scale (i.e. PPS).Cost-effectives analysis will be also carried out by inputting direct and indirect costs in relation to outcomes. Study visits are scheduled at baseline,14±2 days, 3 and 5 months after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CLOPIDOGREL 75 mg qd | Experimental | Drug: P2Y12 inhibitor de-escalation50 patients treated with clopidogrel 75mg |
| PRASUGREL 5mg qd | Experimental | Drug: P2Y12 inhibitor de-escalation50 patients treated with prasugrel 5mg |
| TICAGRELOR 60mg bid | Experimental | Drug: P2Y12 inhibitor de-escalation50 patients treated with ticagrelor 60mg bid |
| Continue Potent P2Y12i Full-Dose | Active comparator | Drug: P2Y12 inhibitor de-escalation50 patients in the full-dose potent P2Y12 inhibitor (prasugrel 10 mg or ticagrelor 90 mg bid according to prior prescription) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| P2Y12 inhibitor de-escalationComparing, in patients at High Bleeding Risk (HBR) after a recent Acute Coronary Syndrome (ACS), continuation of full-dose potent P2Y12 inhibitor with a P2Y12i de-escalation strategy transitioning to clopidogrel 75mg, prasugrel 5mg or ticagrelor 60mg/bid. | Drug | CLOPIDOGREL 75 mg qd, Continue Potent P2Y12i Full-Dose, PRASUGREL 5mg qd, TICAGRELOR 60mg bid |
Primary outcome
Proportion of Patients Achieving Optimal Platelet Reactivity (OPR) at peak level following Drug Maintenance Dose (MD) Using the VerifyNow System
Time frame: 2 hours after drug MD at 14±2 days from study inclusion
The incidence of optimal platelet reactivity (OPR) measured by means of the VerifyNow system. OPR will be defined as a PRU between 85 and 208 reactivity units according to international expert consensus.
6 secondary outcomes
Incidence of Bleeding Events According to Multiple Bleeding Definitions
Time frame: 5 Months after enrollment
Platelet reactive units (PRU) at VerifyNow system
Time frame: baseline, 2 hours after the first treatment administration and before MD at 14±2 days from study inclusion
Proportion of high platelet reactivity (HPR) and the proportion of low platelet reactivity (LPR) measured through the VerifyNow system
Time frame: baseline, 2 hours after the first treatment administration, before MD at 14±2 days from study inclusion and at 2 hours after drug MD administration at 14±2 days
Platelet-derived thrombogenicity at Total Thrombus Formation (T-TAS)
Time frame: baseline, 2 hours after the first treatment administration, before and after MD at 14±2 days from study inclusion.
Adverse clinical event
Time frame: 14±2 days, 3 and 5 months from study inclusion
Cost-effectiveness
Time frame: 5 Months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Derived from this study: PubMed 42567765Costa F, Vizzari G, Zecchino S, Galli M, Montalto C, Carciotto G, Quadri G, Vergallo R, Castriota F, Soraci E, Magliarditi A, Giudice SL, Iuvara G, Munafo A, Giannino F, Pallante F, Franzino M, Teresi L, Piccolo R, Varbella F, Musumeci G, Di Bella G, Ortega-Paz L, Angiolillo DJ, Micari A. De-escalation of antiplatelet therapy to evaluate platelet reactivity and clinical outcomes after coronary stenting in patients at high bleeding risk and recent acute coronary syndrome: Rationale and design of the DESC-HBR trial. Cardiovasc Revasc Med. 2026 Aug 4:S1553-8389(26)00334-9. doi: 10.1016/j.carrev.2026.07.022. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Dual Antiplatelet Therapy
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
RecruitingPhase 3
Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
RecruitingPhase 3
Comparing High and lOw-dose asPirin With Dual anTIplatelet Therapy for Three Months Using prasUgrel and aSpirin Following Coronary Artery Bypass Grafting. (OPTIMUS-CABG Trial)
Chronic Coronary Syndrome, Stable Coronary Artery Disease CAD
Recruiting
Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy
Acute Coronary Syndromes (ACS), Coronary Artery Disease (CAD)
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 3 study testing P2Y12 inhibitor de-escalation in people with Dual Antiplatelet Therapy and Acute Coronary Syndrome, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Aug 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 Italy. 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 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?
Contact Francesco Costa, MD, PhD (+39090221 ext. 2341, francesco.costa@unime.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Achieving Optimal Platelet Reactivity (OPR) at peak level following Drug Maintenance Dose (MD) Using the VerifyNow System (time frame: 2 hours after drug MD at 14±2 days from study inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05903976, which also lists 1 linked publication.
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 23 Aug 2023.