Carotid Atherosclerotic PlaquePhase 1/2PROMISENCT07680595
Prospective Management of Plaque Instability With Statins and Extra Folic Acid
A Phase 1/2 study testing Atorvastatin plus folic acid and Atorvastatin in people with Carotid Atherosclerotic Plaque, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a prospective, exploratory, cohort clinical study aiming to further investigate the direct impact of folic acid on the stability of carotid atherosclerotic plaques, building upon substantial clinical evidence confirming that folic acid supplementation reduces the risk of stroke in hypertensive patients… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carotid Atherosclerotic Plaque
- What is being tested?
- Atorvastatin plus folic acid and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Dec 2027
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated written informed consent form (version approved by the Ethics Committee);
- Voluntary participation and commitment to comply with the study protocol;
- Aged 18 to 75 years, regardless of sex;
- Confirmed carotid plaque by ultrasound or computed tomography angiography (CTA), defined-according to the Expert Consensus on Standardized Ultrasound Operation and Reporting of Carotid Atherosclerotic Plaques (2025, Shanghai)-as the presence of at least one lesion with a carotid intima-media thickness (cIMT) ≥ 1.5 mm or plaque formation;
- Able to cooperate and complete the 6-month study follow-up, including regular imaging examinations and blood sample collections.
Who cannot join
- History of plaque excision or interventional procedures, such as carotid endarterectomy (CEA) or carotid artery stenting (CAS);
- History of severe hepatic or renal impairment, malignancies, autoimmune diseases, or psychiatric disorders;
- Pregnant or lactating women;
- Hypersensitivity (or allergy) to any components of the study medications;
- Current or long-term regular use of any dietary supplements or medications that may significantly affect the folate metabolic cycle (e.g., vitamin B6, vitamin B12, multivitamins, etc.).
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
Shanghai Jiao Tong University Medical School Affiliated Ruijing Hospital
Shanghai, Shanghai Municipality, 200433
Yudong Sun, 18818263589, drsunyudong@hotmail.com
About this study
Official title: A Prospective, Exploratory, Cohort Clinical Study Comparing the Effects of Oral Statins With or Without Folic Acid on Carotid Plaque Stability.
This is a prospective, exploratory, cohort clinical study aiming to further investigate the direct impact of folic acid on the stability of carotid atherosclerotic plaques, building upon substantial clinical evidence confirming that folic acid supplementation reduces the risk of stroke in hypertensive patients, thereby providing a basis for subsequent confirmatory randomized controlled trials. The study will enroll patients with carotid plaques who have not undergone carotid endarterectomy or stent implantation, with lesions defined-according to the Expert Consensus on Standardized Ultrasound Operation and Reporting of Carotid Atherosclerotic Plaques (2025, Shanghai)-as the presence of at least one site with a carotid intima-media thickness (cIMT) ≥ 1.5 mm or visible plaque formation. Participants will be allocated into Cohort 1 (statin therapy) and Cohort 2 (statin therapy plus folic acid); Cohort 1 will receive oral atorvastatin 20 mg daily, while Cohort 2 will receive an additional oral folic acid 5 mg daily on top of the 20 mg oral atorvastatin regimen, both for a continuous duration of 6 months. Statin therapy in both groups will be standardized and managed in accordance with current clinical guidelines, and all subjects will undergo comprehensive evaluations at baseline and after the 6-month intervention. The primary endpoint is the change in carotid plaque thickness at 6 months post-treatment, while secondary endpoints encompass changes in maximum plaque diameter, analysis of plaque composition ratio, and the regulatory effects on serum metabolic markers and the peripheral immune microenvironment, alongside continuous monitoring of treatment-related adverse events throughout the study to comprehensively evaluate overall safety and tolerability.
- Conditions
- Carotid Atherosclerotic Plaque
- Being tested
- Atorvastatin plus folic acid, Atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin plus folic acidDrug
Patients will receive oral folic acid 5 mg daily plus 20 mg atorvastatin regimen, with both treatments continuing for a duration of 6 months
AtorvastatinDrug
Patients will receive 20 mg atorvastatin regimen for a duration of 6 months
| Study group | Role | What they receive |
|---|---|---|
| Statin + Folic acid | Experimental | Not described Receives: Drug: Atorvastatin plus folic acid |
| Statin | Active comparator | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of oral folic acid combined with statins on carotid plaque thickness
Change from baseline in carotid plaque thickness at 6 months post-treatment
Measured: 6 months
Secondary outcomes (4)
To investigate the effect of oral folic acid combined with statins on the maximum diameter of carotid plaques;
Changes in maximum plaque diameter
Measured: 6 months
To investigate the changes in plaque composition ratios following the administration of oral folic acid combined with statins-including changes in intraplaque calcification area, fibrous cap thickness, intraplaque neovascularization, echo intensity.
Plaque composition ratio: To observe post-treatment changes in intraplaque calcification area and fibrous cap thickness; to quantify intraplaque neovascularization density via contrast-enhanced ultrasound (CEUS); and to analyze changes in plaque echogenicity (grayscale values) in order to evaluate the stability of plaque components
Measured: 6 months
To evaluate the impact on the proportions of peripheral blood B-cell subsets (via flow cytometry) and serum IgM/IgG titers (via ELISA)
Determination of peripheral blood B-cell subset proportions (via flow cytometry) and serum IgM/IgG titers (via ELISA)
Measured: 6 months
Safety and Tolerability: To monitor the incidence of adverse events (AEs) during the treatment period. This includes, but is not limited to, drug-specific safety profiles (e.g., gastrointestinal reactions, hepatic and renal dysfunction, and allergic reac
Safety and tolerability: To record the incidence rate of adverse events (AEs) during the treatment period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Mar 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Carotid Atherosclerotic PlaqueStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680595
- Sponsor's protocol ID
- RX-2006-001
- Acronym
- PROMISE
- Status last verified
- Mar 2026
- First submitted
- 22 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zeng Y, Chen YB, Pan BZ, Zhang DW. Complete mitochondrial genome of Schizopygopsis malacanthus (Teleostei: Cypriniformes: Cyprinidae). Mitochondrial DNA A DNA Mapp Seq Anal. 2016;27(2):1405-6. doi: 10.3109/19401736.2014.947602. Epub 2014 Aug 8.
PubMed 25103444Hartert M, Mann WJ, Senbaklavaci O. Relocation of an infected tracheostoma: anterior mediastinal tracheostomy as Mission:Impossible. Interact Cardiovasc Thorac Surg. 2021 Jul 26;33(2):319-321. doi: 10.1093/icvts/ivab071.
PubMed 33792686Yang YY, Gao ZX, Mao ZH, Liu DW, Liu ZS, Wu P. Identification of ULK1 as a novel mitophagy-related gene in diabetic nephropathy. Front Endocrinol (Lausanne). 2023 Jan 18;13:1079465. doi: 10.3389/fendo.2022.1079465. eCollection 2022.
PubMed 36743936Fernandez DM, Rahman AH, Fernandez NF, Chudnovskiy A, Amir ED, Amadori L, Khan NS, Wong CK, Shamailova R, Hill CA, Wang Z, Remark R, Li JR, Pina C, Faries C, Awad AJ, Moss N, Bjorkegren JLM, Kim-Schulze S, Gnjatic S, Ma'ayan A, Mocco J, Faries P, Merad M, Giannarelli C. Single-cell immune landscape of human atherosclerotic plaques. Nat Med. 2019 Oct;25(10):1576-1588. doi: 10.1038/s41591-019-0590-4. Epub 2019 Oct 7.
PubMed 31591603Shibata H, Yasumi T, Shimodera S, Hiejima E, Izawa K, Kawai T, Shirakawa R, Wada T, Nishikomori R, Horiuchi H, Ohara O, Ishii E, Heike T. Human CTL-based functional analysis shows the reliability of a munc13-4 protein expression assay for FHL3 diagnosis. Blood. 2018 May 3;131(18):2016-2025. doi: 10.1182/blood-2017-10-812503. Epub 2018 Mar 16.
PubMed 29549174Clasca F, Rubio-Garrido P, Jabaudon D. Unveiling the diversity of thalamocortical neuron subtypes. Eur J Neurosci. 2012 May;35(10):1524-32. doi: 10.1111/j.1460-9568.2012.08033.x.
PubMed 22606998Huo Y, Li J, Qin X, Huang Y, Wang X, Gottesman RF, Tang G, Wang B, Chen D, He M, Fu J, Cai Y, Shi X, Zhang Y, Cui Y, Sun N, Li X, Cheng X, Wang J, Yang X, Yang T, Xiao C, Zhao G, Dong Q, Zhu D, Wang X, Ge J, Zhao L, Hu D, Liu L, Hou FF; CSPPT Investigators. Efficacy of folic acid therapy in primary prevention of stroke among adults with hypertension in China: the CSPPT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1325-35. doi: 10.1001/jama.2015.2274.
PubMed 25771069Qin X, Xu M, Zhang Y, Li J, Xu X, Wang X, Xu X, Huo Y. Effect of folic acid supplementation on the progression of carotid intima-media thickness: a meta-analysis of randomized controlled trials. Atherosclerosis. 2012 Jun;222(2):307-13. doi: 10.1016/j.atherosclerosis.2011.12.007. Epub 2011 Dec 9.
PubMed 22209480Ntaios G, Savopoulos C, Karamitsos D, Economou I, Destanis E, Chryssogonidis I, Pidonia I, Zebekakis P, Polatides C, Sion M, Grekas D, Hatzitolios A. The effect of folic acid supplementation on carotid intima-media thickness in patients with cardiovascular risk: a randomized, placebo-controlled trial. Int J Cardiol. 2010 Aug 6;143(1):16-9. doi: 10.1016/j.ijcard.2009.01.023. Epub 2009 Feb 8.
PubMed 19201496Laugaland K, Aase K, Waring J. Hospital discharge of the elderly--an observational case study of functions, variability and performance-shaping factors. BMC Health Serv Res. 2014 Aug 30;14:365. doi: 10.1186/1472-6963-14-365.
PubMed 25175924Zamani M, Rezaiian F, Saadati S, Naseri K, Ashtary-Larky D, Yousefi M, Golalipour E, Clark CCT, Rastgoo S, Asbaghi O. The effects of folic acid supplementation on endothelial function in adults: a systematic review and dose-response meta-analysis of randomized controlled trials. Nutr J. 2023 Feb 24;22(1):12. doi: 10.1186/s12937-023-00843-y.
PubMed 36829207Carnicer R, Navarro MA, Arbones-Mainar JM, Acin S, Guzman MA, Surra JC, Arnal C, de Las Heras M, Blanco-Vaca F, Osada J. Folic acid supplementation delays atherosclerotic lesion development in apoE-deficient mice. Life Sci. 2007 Jan 23;80(7):638-43. doi: 10.1016/j.lfs.2006.10.014. Epub 2006 Nov 10.
PubMed 17118406Barwick BG, Scharer CD, Martinez RJ, Price MJ, Wein AN, Haines RR, Bally APR, Kohlmeier JE, Boss JM. B cell activation and plasma cell differentiation are inhibited by de novo DNA methylation. Nat Commun. 2018 May 15;9(1):1900. doi: 10.1038/s41467-018-04234-4.
PubMed 29765016Blanco M, Vazquez JA, Perez-Martin RI, Sotelo CG. Hydrolysates of Fish Skin Collagen: An Opportunity for Valorizing Fish Industry Byproducts. Mar Drugs. 2017 May 5;15(5):131. doi: 10.3390/md15050131.
PubMed 28475143Ciginskiene A, Dambrauskiene A, Rello J, Adukauskiene D. Ventilator-Associated Pneumonia due to Drug-Resistant Acinetobacter baumannii: Risk Factors and Mortality Relation with Resistance Profiles, and Independent Predictors of In-Hospital Mortality. Medicina (Kaunas). 2019 Feb 13;55(2):49. doi: 10.3390/medicina55020049.
PubMed 30781896
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Exploratory, Cohort Clinical Study Comparing the Effects of Oral Statins With or Without Folic Acid on Carotid Plaque Stability.
- ClinicalTrials.gov ID
- NCT07680595
- Acronym / sponsor ID
- PROMISE / RX-2006-001
- Conditions
- Carotid Atherosclerotic Plaque
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jul 2026 (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.
This is a prospective, exploratory, cohort clinical study aiming to further investigate the direct impact of folic acid on the stability of carotid atherosclerotic plaques, building upon substantial clinical evidence confirming that folic acid supplementation reduces the risk of stroke in hypertensive patients, thereby providing a basis for subsequent confirmatory randomized controlled trials. The study will enroll patients with carotid plaques who have not undergone carotid endarterectomy or stent implantation, with lesions defined-according to the Expert Consensus on Standardized Ultrasound Operation and Reporting of Carotid Atherosclerotic Plaques (2025, Shanghai)-as the presence of at least one site with a carotid intima-media thickness (cIMT) ≥ 1.5 mm or visible plaque formation. Participants will be allocated into Cohort 1 (statin therapy) and Cohort 2 (statin therapy plus folic acid); Cohort 1 will receive oral atorvastatin 20 mg daily, while Cohort 2 will receive an additional oral folic acid 5 mg daily on top of the 20 mg oral atorvastatin regimen, both for a continuous duration of 6 months. Statin therapy in both groups will be standardized and managed in accordance with current clinical guidelines, and all subjects will undergo comprehensive evaluations at baseline and after the 6-month intervention. The primary endpoint is the change in carotid plaque thickness at 6 months post-treatment, while secondary endpoints encompass changes in maximum plaque diameter, analysis of plaque composition ratio, and the regulatory effects on serum metabolic markers and the peripheral immune microenvironment, alongside continuous monitoring of treatment-related adverse events throughout the study to comprehensively evaluate overall safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin + Folic acid | Experimental | Drug: Atorvastatin plus folic acid |
| Statin | Active comparator | Drug: Atorvastatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed and dated written informed consent form (version approved by the Ethics Committee);
- Voluntary participation and commitment to comply with the study protocol;
- Aged 18 to 75 years, regardless of sex;
- Confirmed carotid plaque by ultrasound or computed tomography angiography (CTA), defined-according to the Expert Consensus on Standardized Ultrasound Operation and Reporting of Carotid Atherosclerotic Plaques (2025, Shanghai)-as the presence of at least one lesion with a carotid intima-media thickness (cIMT) ≥ 1.5 mm or plaque formation;
- Able to cooperate and complete the 6-month study follow-up, including regular imaging examinations and blood sample collections.
Key exclusion criteria (5 listed)
- History of plaque excision or interventional procedures, such as carotid endarterectomy (CEA) or carotid artery stenting (CAS);
- History of severe hepatic or renal impairment, malignancies, autoimmune diseases, or psychiatric disorders;
- Pregnant or lactating women;
- Hypersensitivity (or allergy) to any components of the study medications;
- Current or long-term regular use of any dietary supplements or medications that may significantly affect the folate metabolic cycle (e.g., vitamin B6, vitamin B12, multivitamins, etc.).
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 |
|---|---|---|
| Atorvastatin plus folic acidPatients will receive oral folic acid 5 mg daily plus 20 mg atorvastatin regimen, with both treatments continuing for a duration of 6 months | Drug | Statin + Folic acid |
| AtorvastatinPatients will receive 20 mg atorvastatin regimen for a duration of 6 months | Drug | Statin |
Primary outcome
Effects of oral folic acid combined with statins on carotid plaque thickness
Time frame: 6 months
Change from baseline in carotid plaque thickness at 6 months post-treatment
4 secondary outcomes
To investigate the effect of oral folic acid combined with statins on the maximum diameter of carotid plaques;
Time frame: 6 months
To investigate the changes in plaque composition ratios following the administration of oral folic acid combined with statins-including changes in intraplaque calcification area, fibrous cap thickness, intraplaque neovascularization, echo intensity.
Time frame: 6 months
To evaluate the impact on the proportions of peripheral blood B-cell subsets (via flow cytometry) and serum IgM/IgG titers (via ELISA)
Time frame: 6 months
Safety and Tolerability: To monitor the incidence of adverse events (AEs) during the treatment period. This includes, but is not limited to, drug-specific safety profiles (e.g., gastrointestinal reactions, hepatic and renal dysfunction, and allergic reac
Time frame: 6 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 2 Jul 2026.
- Results publication: PubMed 25103444Zeng Y, Chen YB, Pan BZ, Zhang DW. Complete mitochondrial genome of Schizopygopsis malacanthus (Teleostei: Cypriniformes: Cyprinidae). Mitochondrial DNA A DNA Mapp Seq Anal. 2016;27(2):1405-6. doi: 10.3109/19401736.2014.947602. Epub 2014 Aug 8.
- Results publication: PubMed 33792686Hartert M, Mann WJ, Senbaklavaci O. Relocation of an infected tracheostoma: anterior mediastinal tracheostomy as Mission:Impossible. Interact Cardiovasc Thorac Surg. 2021 Jul 26;33(2):319-321. doi: 10.1093/icvts/ivab071.
- Results publication: PubMed 36743936Yang YY, Gao ZX, Mao ZH, Liu DW, Liu ZS, Wu P. Identification of ULK1 as a novel mitophagy-related gene in diabetic nephropathy. Front Endocrinol (Lausanne). 2023 Jan 18;13:1079465. doi: 10.3389/fendo.2022.1079465. eCollection 2022.
- Results publication: PubMed 31591603Fernandez DM, Rahman AH, Fernandez NF, Chudnovskiy A, Amir ED, Amadori L, Khan NS, Wong CK, Shamailova R, Hill CA, Wang Z, Remark R, Li JR, Pina C, Faries C, Awad AJ, Moss N, Bjorkegren JLM, Kim-Schulze S, Gnjatic S, Ma'ayan A, Mocco J, Faries P, Merad M, Giannarelli C. Single-cell immune landscape of human atherosclerotic plaques. Nat Med. 2019 Oct;25(10):1576-1588. doi: 10.1038/s41591-019-0590-4. Epub 2019 Oct 7.
- Results publication: PubMed 29549174Shibata H, Yasumi T, Shimodera S, Hiejima E, Izawa K, Kawai T, Shirakawa R, Wada T, Nishikomori R, Horiuchi H, Ohara O, Ishii E, Heike T. Human CTL-based functional analysis shows the reliability of a munc13-4 protein expression assay for FHL3 diagnosis. Blood. 2018 May 3;131(18):2016-2025. doi: 10.1182/blood-2017-10-812503. Epub 2018 Mar 16.
- Results publication: PubMed 22606998Clasca F, Rubio-Garrido P, Jabaudon D. Unveiling the diversity of thalamocortical neuron subtypes. Eur J Neurosci. 2012 May;35(10):1524-32. doi: 10.1111/j.1460-9568.2012.08033.x.
- Results publication: PubMed 25771069Huo Y, Li J, Qin X, Huang Y, Wang X, Gottesman RF, Tang G, Wang B, Chen D, He M, Fu J, Cai Y, Shi X, Zhang Y, Cui Y, Sun N, Li X, Cheng X, Wang J, Yang X, Yang T, Xiao C, Zhao G, Dong Q, Zhu D, Wang X, Ge J, Zhao L, Hu D, Liu L, Hou FF; CSPPT Investigators. Efficacy of folic acid therapy in primary prevention of stroke among adults with hypertension in China: the CSPPT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1325-35. doi: 10.1001/jama.2015.2274.
- Results publication: PubMed 22209480Qin X, Xu M, Zhang Y, Li J, Xu X, Wang X, Xu X, Huo Y. Effect of folic acid supplementation on the progression of carotid intima-media thickness: a meta-analysis of randomized controlled trials. Atherosclerosis. 2012 Jun;222(2):307-13. doi: 10.1016/j.atherosclerosis.2011.12.007. Epub 2011 Dec 9.
- Results publication: PubMed 19201496Ntaios G, Savopoulos C, Karamitsos D, Economou I, Destanis E, Chryssogonidis I, Pidonia I, Zebekakis P, Polatides C, Sion M, Grekas D, Hatzitolios A. The effect of folic acid supplementation on carotid intima-media thickness in patients with cardiovascular risk: a randomized, placebo-controlled trial. Int J Cardiol. 2010 Aug 6;143(1):16-9. doi: 10.1016/j.ijcard.2009.01.023. Epub 2009 Feb 8.
- Results publication: PubMed 25175924Laugaland K, Aase K, Waring J. Hospital discharge of the elderly--an observational case study of functions, variability and performance-shaping factors. BMC Health Serv Res. 2014 Aug 30;14:365. doi: 10.1186/1472-6963-14-365.
- Results publication: PubMed 36829207Zamani M, Rezaiian F, Saadati S, Naseri K, Ashtary-Larky D, Yousefi M, Golalipour E, Clark CCT, Rastgoo S, Asbaghi O. The effects of folic acid supplementation on endothelial function in adults: a systematic review and dose-response meta-analysis of randomized controlled trials. Nutr J. 2023 Feb 24;22(1):12. doi: 10.1186/s12937-023-00843-y.
- Results publication: PubMed 17118406Carnicer R, Navarro MA, Arbones-Mainar JM, Acin S, Guzman MA, Surra JC, Arnal C, de Las Heras M, Blanco-Vaca F, Osada J. Folic acid supplementation delays atherosclerotic lesion development in apoE-deficient mice. Life Sci. 2007 Jan 23;80(7):638-43. doi: 10.1016/j.lfs.2006.10.014. Epub 2006 Nov 10.
- Individual participant dataSharing planned: Yes
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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 1/2 study testing Atorvastatin plus folic acid and Atorvastatin in people with Carotid Atherosclerotic Plaque, run by Ruijin Hospital 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 5 inclusion and 5 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 2 Jul 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Junyi Yan, M.D. (+8613480161737, drsunyudong@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of oral folic acid combined with statins on carotid plaque thickness (time frame: 6 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 NCT07680595, which also lists 20 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 2 Jul 2026.