Prospective Management of Plaque Instability With Statins and Extra Folic Acid (PROMISE)
2026년 7월 1일 업데이트: Ruijin Hospital
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.
연구 개요
연구 유형
중재적
등록 (추정된)
180
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Junyi Yan, M.D.
- 전화번호: +8613480161737
- 이메일: drsunyudong@hotmail.com
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200433
- 모병
- Shanghai Jiao Tong University Medical School Affiliated Ruijing Hospital
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연락하다:
- Yudong Sun
- 전화번호: 18818263589
- 이메일: drsunyudong@hotmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 스타틴
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Patients will receive 20 mg atorvastatin regimen for a duration of 6 months
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실험적: Statin + Folic acid
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Patients will receive oral folic acid 5 mg daily plus 20 mg atorvastatin regimen, with both treatments continuing for a duration of 6 months
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Effects of oral folic acid combined with statins on carotid plaque thickness
기간: 6 months
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Change from baseline in carotid plaque thickness at 6 months post-treatment
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To investigate the effect of oral folic acid combined with statins on the maximum diameter of carotid plaques;
기간: 6 months
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Changes in maximum plaque diameter
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6 months
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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.
기간: 6 months
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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
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6 months
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To evaluate the impact on the proportions of peripheral blood B-cell subsets (via flow cytometry) and serum IgM/IgG titers (via ELISA)
기간: 6 months
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Determination of peripheral blood B-cell subset proportions (via flow cytometry) and serum IgM/IgG titers (via ELISA)
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6 months
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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
기간: 6 months
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Safety and tolerability: To record the incidence rate of adverse events (AEs) during the treatment period
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6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 3월 1일
기본 완료 (추정된)
2027년 9월 1일
연구 완료 (추정된)
2027년 12월 31일
연구 등록 날짜
최초 제출
2026년 6월 22일
QC 기준을 충족하는 최초 제출
2026년 7월 1일
처음 게시됨 (실제)
2026년 7월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 1일
마지막으로 확인됨
2026년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RX-2006-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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