ACS - Acute Coronary SyndromePhase 4NCT06283888
CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection After Complex Percutaneous Coronary Intervention
A Phase 4 study testing CYP2C19 Genotype Guided DAPT and Conventional DAPT in people with ACS - Acute Coronary Syndrome and CYP2C19 Polymorphism, run by Zunyi Medical College at 1 site in China.
Trial summary
In Ease Asia clinical trials, P2Y12 inhibitor (ticagrelor or clopidogrel) monotherapy after 3-month dual antiplatelet therapy (DAPT) resulted in a lower incidence of clinically significant bleeding, without increasing risk of major adverse cardiac and cerebrovascular events, even if acute coronary syndrome (ACS)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ACS - Acute Coronary Syndrome, CYP2C19 Polymorphism
- What is being tested?
- CYP2C19 Genotype Guided DAPT and Conventional DAPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Dec 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Criteria:
- Patients aged between 18-80 years old.
- Patients with ACS (UA/NSTEMI/STEMI) undergoing PCI.
- Patients will be treated with DAPT (P2Y12 inhibitors+aspirin) for at least 3 months.
- Patients are willing to provide a DNA sample (via blood draw) for CYP2C19 genotyping.
- Patients provide written informed consent before enrollment.
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- Angiographic Criteria (meet at least 1 of the following characteristics):
- Thrombotic target lesion.
- Calcified target lesion requiring rotational atherectomy or intravascular lithotripsy
- Multivessel (≥2 vessels) disease will be treated.
- Multi-target lesions (≥3 lesions) will be treated.
- Multi-stent (≥3 stents) will be implanted.
- Total stent length≥60 mm.
- Bifurcation lesion requiring at least 2 stents.
- PCI for left main.
- PCI for chronic total occlusion.
- PCI for bypass graft.
Who cannot join
- Patient with known CYP2C19 genotype before randomization.
- Anticipated discontinuation of clopidogrel or ticagrelor within the 12-month follow-up period.
- Planned surgery within 90 days.
- Requiring oral anticoagulation therapy (eg, atrial fibrillation, deep vein thrombosis, pulmonary thromboembolism)
- Intracranial/gastrointestinal/urogenital bleeding within 6 months.
- Active bleeding or bleeding diathesis, thrombocytopenia (platelet <100,000/mL) or hemoglobin <10 g/dL
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- Hepatic dysfunction (serum liver enzyme>3 times the normal limit)
- Renal failure (eGFR <15 ml/min/1.73m2 or requiring dialysis)
- Concomitant therapy with a strong CYP3A4 inhibitor or inducer
- Life expectancy < 1 year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563003
Cai De Jin, MD, 86+173-8576-9997, jincaide@zmu.edu.cn
Yan Yan Jin, MD, PhD, 86+157-7229-0925, jinyanyan850925@163.com
About this study
Official title: Safety and Efficacy of CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection Versus Conventional Antiplatelet Therapy After Complex Percutaneous Coronary Intervention: The PRECISE-PCI Randomized Clinical Trial
In Ease Asia clinical trials, P2Y12 inhibitor (ticagrelor or clopidogrel) monotherapy after 3-month dual antiplatelet therapy (DAPT) resulted in a lower incidence of clinically significant bleeding, without increasing risk of major adverse cardiac and cerebrovascular events, even if acute coronary syndrome (ACS) following complex percutaneous coronary intervention (PCI) when compared with standard DAPT. Although better understood "East Asian Paradox", finding the right CYP2C19 genotype-guided P2Y12 inhibitor selection to balance maintaining ischaemic prevention and less bleeding remains a topic in real-world clinical practice.
Read the detailed description
In the PRECISE-PCI (CYP2C19 Genotype-Guided P2Y12 RECeptor Inhibitor SElection After Complex PCI) trial, the investigators aim to evaluate the safety and efficacy of CYP2C19 genotype-guided P2Y12 receptor inhibitor selection, as compared with conventional therapy in Chinese with ACS undergoing complex PCI All eligible ACS patients will be received DAPT (ticagrelor 180 mg or clopidogrel 300/600 mg plus aspirin 300 mg loading) before PCI. Subsequently to be randomly assigned into the genotype-guided group (CPY2C19 *2 or *3 carrier: ticagrelor 60 mg bid, or 45mg bid if <50 kg, ≥75 years; CPY2C19 *2 or *3 non-carrier: clopidogrel 75 mg qd in combination with aspirin 100 mg qd) and conventional group (ticagrelor 90 mg bid or clopidogrel 75 mg qd in combination with aspirin 100 mg qd). At post-PCI 3 months, both groups will be treated with mono-ticagrelor/clopidogrel without aspirin therapy for a further 9 months.
The primary endpoint is focusing on the net adverse clinical events (NACEs, a composite of cardiac death, non-fatal myocardial infarction, target vessel/lesion revascularization, stroke, or BARC-defined clinically significant bleeding type 2, 3, or 5) during 12-month follow-ups.
- Being tested
- CYP2C19 Genotype Guided DAPT, Conventional DAPT
- Keywords
- CYP2C19 Genotype, P2Y12 Receptor Inhibitor, Complex PCI
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYP2C19 Genotype Guided DAPTDrug
Also called Guided DAPT
Patients with *2 or *3 carrier will be received ticagrelor 60mg or 45mg bid (if <50 kg, ≥75 years) + aspirin 100 mg qd; Patients with *2 or *3 non-carrier will be received clopidogrel 75mg qd + aspirin 100 mg qd
Conventional DAPTDrug
Also called Unguided DAPT
Patients will be conventionally received ticagrelor 90mg bid or clopidogrel 75mg qd + aspirin 100 mg qd
| Study group | Role | What they receive |
|---|---|---|
| CYP2C19 Genotype Guided DAPT | Experimental | Patients with CYP2C19 *2 or *3 carrier will be received ticagrelor 60mg or 45mg bid (if <50 kg, ≥75 years) + aspirin 100 mg Patients with CYP2C19 *2 or *3 non-carrier will be received clopidogrel 75mg qd + aspirin 100 mg qd
At post-PCI 3 months, monotherapy P2Y12 inhibitor (ticagrelor or clopidogrel) will be treated for a further 9 months. Receives: Drug: CYP2C19 Genotype Guided DAPT |
| Conventional DAPT | Experimental | Patients will be conventionally received ticagrelor 90mg bid or clopidogrel 75mg qd + aspirin 100 mg qd
At post-PCI 3 months, monotherapy P2Y12 inhibitor (ticagrelor or clopidogrel) will be treated for a further 9 months. Receives: Drug: Conventional DAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
NACE (net adverse clinical event)
The incidence of NACE (composite of cardiac death, non-fatal myocardial infarction, target vessel/lesion revascularization, stroke, or clinically significant bleeding according to BARC criteria).
Measured: At 12 months
Secondary outcomes (2)
Incidence of clinically significant bleeding
The Bleeding Academic Research Consortium (BARC)-defined clinically significant bleeding (type 2, 3, or 5 bleeding) as follows:
Type 2: Any overt, actionable sign of hemorrhage, requiring nonsurgical, medical intervention by a healthcare professional; Leading to hospitalization or increased level of care; Prompting evaluation.
Type 3: Clinical, laboratory, and/or imaging evidence of bleeding with specific healthcare provider responses.
Type 3a: Overt bleeding plus hemoglobin drop of 3 to 5 g/dL; Any transfusion with overt bleeding.
Type 3b: Overt bleeding plus hemoglobin drop ≥5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring intravenous vasoactive agents.
Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision.
Type 5: Fatal bleeding is bleeding that directly causes death with no other explainable cause.
Measured: At 12 months
Incidence of MACCE
The incidence of major adverse cardiac and cerebrovascular event (MACCE), is composite of cardiac death, non-fatal myocardial infarction, target vessel/lesion revascularization, or stroke.
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 posted28 Feb 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ACS - Acute Coronary SyndromeStudies 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zunyi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cai De Jin, MD, Zunyi Medical College
- Investigators
- Cai De Jin, Principal investigator, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283888
- Sponsor's protocol ID
- PRECISE-PCI
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pereira NL, Farkouh ME, So D, Lennon R, Geller N, Mathew V, Bell M, Bae JH, Jeong MH, Chavez I, Gordon P, Abbott JD, Cagin C, Baudhuin L, Fu YP, Goodman SG, Hasan A, Iturriaga E, Lerman A, Sidhu M, Tanguay JF, Wang L, Weinshilboum R, Welsh R, Rosenberg Y, Bailey K, Rihal C. Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial. JAMA. 2020 Aug 25;324(8):761-771. doi: 10.1001/jama.2020.12443.
PubMed 32840598Kim BK, Hong SJ, Cho YH, Yun KH, Kim YH, Suh Y, Cho JY, Her AY, Cho S, Jeon DW, Yoo SY, Cho DK, Hong BK, Kwon H, Ahn CM, Shin DH, Nam CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y; TICO Investigators. Effect of Ticagrelor Monotherapy vs Ticagrelor With Aspirin on Major Bleeding and Cardiovascular Events in Patients With Acute Coronary Syndrome: The TICO Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2407-2416. doi: 10.1001/jama.2020.7580.
PubMed 32543684Hahn JY, Song YB, Oh JH, Chun WJ, Park YH, Jang WJ, Im ES, Jeong JO, Cho BR, Oh SK, Yun KH, Cho DK, Lee JY, Koh YY, Bae JW, Choi JW, Lee WS, Yoon HJ, Lee SU, Cho JH, Choi WG, Rha SW, Lee JM, Park TK, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC; SMART-CHOICE Investigators. Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention: The SMART-CHOICE Randomized Clinical Trial. JAMA. 2019 Jun 25;321(24):2428-2437. doi: 10.1001/jama.2019.8146.
PubMed 31237645Jin C, Kim MH, Guo LZ, Jin E, Shin ES, Ann SH, Cho YR, Park JS, Kim SJ, Lee MS. Pharmacodynamic study of prasugrel or clopidogrel in non-ST-elevation acute coronary syndrome with CYP2C19 genetic variants undergoing percutaneous coronary intervention (PRAISE-GENE trial). Int J Cardiol. 2020 Apr 15;305:11-17. doi: 10.1016/j.ijcard.2020.01.058. Epub 2020 Jan 25.
PubMed 32029306Jin CD, Kim MH, Song K, Jin X, Lee KM, Park JS, Cho YR, Yun SC, Lee MS. Pharmacodynamics and Outcomes of a De-Escalation Strategy with Half-Dose Prasugrel or Ticagrelor in East Asians Patients with Acute Coronary Syndrome: Results from HOPE-TAILOR Trial. J Clin Med. 2021 Jun 18;10(12):2699. doi: 10.3390/jcm10122699.
PubMed 34207339
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection Versus Conventional Antiplatelet Therapy After Complex Percutaneous Coronary Intervention: The PRECISE-PCI Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06283888
- Acronym / sponsor ID
- PRECISE-PCI
- Keywords
- CYP2C19 Genotype, P2Y12 Receptor Inhibitor, Complex PCI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Zunyi Medical CollegeUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 28 Feb 2024 (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.
In Ease Asia clinical trials, P2Y12 inhibitor (ticagrelor or clopidogrel) monotherapy after 3-month dual antiplatelet therapy (DAPT) resulted in a lower incidence of clinically significant bleeding, without increasing risk of major adverse cardiac and cerebrovascular events, even if acute coronary syndrome (ACS) following complex percutaneous coronary intervention (PCI) when compared with standard DAPT. Although better understood "East Asian Paradox", finding the right CYP2C19 genotype-guided P2Y12 inhibitor selection to balance maintaining ischaemic prevention and less bleeding remains a topic in real-world clinical practice.
Detailed description
In the PRECISE-PCI (CYP2C19 Genotype-Guided P2Y12 RECeptor Inhibitor SElection After Complex PCI) trial, the investigators aim to evaluate the safety and efficacy of CYP2C19 genotype-guided P2Y12 receptor inhibitor selection, as compared with conventional therapy in Chinese with ACS undergoing complex PCI All eligible ACS patients will be received DAPT (ticagrelor 180 mg or clopidogrel 300/600 mg plus aspirin 300 mg loading) before PCI. Subsequently to be randomly assigned into the genotype-guided group (CPY2C19 *2 or *3 carrier: ticagrelor 60 mg bid, or 45mg bid if <50 kg, ≥75 years; CPY2C19 *2 or *3 non-carrier: clopidogrel 75 mg qd in combination with aspirin 100 mg qd) and conventional group (ticagrelor 90 mg bid or clopidogrel 75 mg qd in combination with aspirin 100 mg qd). At post-PCI 3 months, both groups will be treated with mono-ticagrelor/clopidogrel without aspirin therapy for a further 9 months.
The primary endpoint is focusing on the net adverse clinical events (NACEs, a composite of cardiac death, non-fatal myocardial infarction, target vessel/lesion revascularization, stroke, or BARC-defined clinically significant bleeding type 2, 3, or 5) during 12-month follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CYP2C19 Genotype Guided DAPT | Experimental | Drug: CYP2C19 Genotype Guided DAPTPatients with CYP2C19 *2 or *3 carrier will be received ticagrelor 60mg or 45mg bid (if <50 kg, ≥75 years) + aspirin 100 mg Patients with CYP2C19 *2 or *3 non-carrier will be received clopidogrel 75mg qd + aspirin 100 mg qd At post-PCI 3 months, monotherapy P2Y12 inhibitor (ticagrelor or clopidogrel) will be treated for a further 9 months. |
| Conventional DAPT | Experimental | Drug: Conventional DAPTPatients will be conventionally received ticagrelor 90mg bid or clopidogrel 75mg qd + aspirin 100 mg qd At post-PCI 3 months, monotherapy P2Y12 inhibitor (ticagrelor or clopidogrel) will be treated for a further 9 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Clinical Criteria:
- Angiographic Criteria (meet at least 1 of the following characteristics):
Key exclusion criteria (10 listed)
- Patient with known CYP2C19 genotype before randomization.
- Anticipated discontinuation of clopidogrel or ticagrelor within the 12-month follow-up period.
- Planned surgery within 90 days.
- Requiring oral anticoagulation therapy (eg, atrial fibrillation, deep vein thrombosis, pulmonary thromboembolism)
- Intracranial/gastrointestinal/urogenital bleeding within 6 months.
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 |
|---|---|---|
| CYP2C19 Genotype Guided DAPTAlso: Guided DAPTPatients with *2 or *3 carrier will be received ticagrelor 60mg or 45mg bid (if <50 kg, ≥75 years) + aspirin 100 mg qd; Patients with *2 or *3 non-carrier will be received clopidogrel 75mg qd + aspirin 100 mg qd | Drug | CYP2C19 Genotype Guided DAPT |
| Conventional DAPTAlso: Unguided DAPTPatients will be conventionally received ticagrelor 90mg bid or clopidogrel 75mg qd + aspirin 100 mg qd | Drug | Conventional DAPT |
Primary outcome
NACE (net adverse clinical event)
Time frame: At 12 months
The incidence of NACE (composite of cardiac death, non-fatal myocardial infarction, target vessel/lesion revascularization, stroke, or clinically significant bleeding according to BARC criteria).
2 secondary outcomes
Incidence of clinically significant bleeding
Time frame: At 12 months
Incidence of MACCE
Time frame: 12 months
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 20 Mar 2024.
- Background: PubMed 32840598Pereira NL, Farkouh ME, So D, Lennon R, Geller N, Mathew V, Bell M, Bae JH, Jeong MH, Chavez I, Gordon P, Abbott JD, Cagin C, Baudhuin L, Fu YP, Goodman SG, Hasan A, Iturriaga E, Lerman A, Sidhu M, Tanguay JF, Wang L, Weinshilboum R, Welsh R, Rosenberg Y, Bailey K, Rihal C. Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial. JAMA. 2020 Aug 25;324(8):761-771. doi: 10.1001/jama.2020.12443.
- Background: PubMed 32543684Kim BK, Hong SJ, Cho YH, Yun KH, Kim YH, Suh Y, Cho JY, Her AY, Cho S, Jeon DW, Yoo SY, Cho DK, Hong BK, Kwon H, Ahn CM, Shin DH, Nam CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y; TICO Investigators. Effect of Ticagrelor Monotherapy vs Ticagrelor With Aspirin on Major Bleeding and Cardiovascular Events in Patients With Acute Coronary Syndrome: The TICO Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2407-2416. doi: 10.1001/jama.2020.7580.
- Background: PubMed 31237645Hahn JY, Song YB, Oh JH, Chun WJ, Park YH, Jang WJ, Im ES, Jeong JO, Cho BR, Oh SK, Yun KH, Cho DK, Lee JY, Koh YY, Bae JW, Choi JW, Lee WS, Yoon HJ, Lee SU, Cho JH, Choi WG, Rha SW, Lee JM, Park TK, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC; SMART-CHOICE Investigators. Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention: The SMART-CHOICE Randomized Clinical Trial. JAMA. 2019 Jun 25;321(24):2428-2437. doi: 10.1001/jama.2019.8146.
- Background: PubMed 32029306Jin C, Kim MH, Guo LZ, Jin E, Shin ES, Ann SH, Cho YR, Park JS, Kim SJ, Lee MS. Pharmacodynamic study of prasugrel or clopidogrel in non-ST-elevation acute coronary syndrome with CYP2C19 genetic variants undergoing percutaneous coronary intervention (PRAISE-GENE trial). Int J Cardiol. 2020 Apr 15;305:11-17. doi: 10.1016/j.ijcard.2020.01.058. Epub 2020 Jan 25.
- Background: PubMed 34207339Jin CD, Kim MH, Song K, Jin X, Lee KM, Park JS, Cho YR, Yun SC, Lee MS. Pharmacodynamics and Outcomes of a De-Escalation Strategy with Half-Dose Prasugrel or Ticagrelor in East Asians Patients with Acute Coronary Syndrome: Results from HOPE-TAILOR Trial. J Clin Med. 2021 Jun 18;10(12):2699. doi: 10.3390/jcm10122699.
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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.
Cai De Jin principal investigator
Zunyi Medical College
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 CYP2C19 Genotype Guided DAPT and Conventional DAPT in people with ACS - Acute Coronary Syndrome and CYP2C19 Polymorphism, run by Zunyi Medical College at 1 site in China.
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 17 inclusion and 10 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 20 Mar 2024. 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 China. 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?
Contact Cai De Jin, MD (86+173-8576-9997, jincaide1118@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NACE (net adverse clinical event) (time frame: At 12 months). 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 NCT06283888, which also lists 5 linked publications.
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 20 Mar 2024.