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The study will evaluate the efficacy of alpha-lipoic acid(α-LA) on mortality in patients with ischemic heart failure (NYHA Class II - IV and EF =< 50%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpha-Lipoic Acid(α-LA) | Experimental | Double blind treatment period consisted of treatment with CHF standard treatments, followed by α-LA 200 mg tid over a total duration of 24 months. |
|
| Placebo | Placebo Comparator | Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha-Lipoic Acid(α-LA) | Drug | 200 mg, po, tid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Had First Occurrence of the Composite Endpoint | either all-cause death or heart failure (HF) hospitalization | up to 24 months |
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Inclusion Criteria:
patients ≥ 18 years of age, male or female.
Patients with a diagnosis of AMI (>30 days) according to the global definition. ③Patients with a diagnosis of CHF (NYHA class II-IV) and reduced ejection fraction (EF =< 50%) and elevated BNP(NT-proBNP≥600pg/ml or BNP≥150pg/ml; NT-proBNP ≥400 pg/mL or BNP ≥100 pg/mL if patients was hospitalized for heart failure within 12months).
Patients must be treated with standardized heart failure medications treatment at a stable dose for at least 4 weeks.
Exclusion Criteria:
Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
allergy to any of the study drugs, drugs of similar chemical classes(Vitamin B) as well as known or suspected contraindications to the study drugs.
Previous history of intolerance to recommended target doses of α-LA.
Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
⑤ Symptomatic hypotension and/or a SBP < 100 mmHg.
â‘¥ Severe liver function abnormalities (ALT or AST more than 3 times of the normal upper limit).
⑦ Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula.
â‘§ Serum potassium > 5.2 mmol/L.
⑨ Pregnant women or women preparing for birth.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Shanghai | 200025 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alpha-Lipoic Acid(α-LA) | Double blind treatment period consisted of treatment with CHF standard treatments, followed by α-LA 200 mg tid over a total duration of 24 months. Alpha-Lipoic Acid(α-LA): 200 mg, po, tid |
| FG001 | Placebo | Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months. Placebos: 200 mg, po, tid |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The primary efficacy endpoints were analyzed using the full analysis set (FAS), which followed the Intent-to-Treat (ITT) principle. Inclusion in the FAS required that participants receive the investigational drug for a minimum of 1 month. 300 patients were randomized in a 1:1 ratio to receive either ALA or a matching placebo. In the ALA group, 12 patients were excluded from the primary analysis. In the placebo group, 11 participants were excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alpha-Lipoic Acid(α-LA) | Double blind treatment period consisted of treatment with CHF standard treatments, followed by α-LA 200 mg tid over a total duration of 24 months. Alpha-Lipoic Acid(α-LA): 200 mg, po, tid |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants That Had First Occurrence of the Composite Endpoint | either all-cause death or heart failure (HF) hospitalization | Posted | Count of Participants | Participants | up to 24 months |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alpha-Lipoic Acid(α-LA) | Double blind treatment period consisted of treatment with CHF standard treatments, followed by α-LA 200 mg tid over a total duration of 24 months. Alpha-Lipoic Acid(α-LA): 200 mg, po, tid |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal symptoms | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hanchuan Chen | Zhongshan hospital, Fudan University | 18459111985 | chenhanchuan66@126.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 5, 2018 | Jun 24, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 1, 2025 | Jun 24, 2025 | SAP_001.pdf |
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| Placebos |
| Drug |
200 mg, po, tid |
|
Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months.
Placebos: 200 mg, po, tid
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 32 |
| 138 |
| 12 |
| 145 |
| 31 |
| 145 |
| EG001 | Placebo | Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months. Placebos: 200 mg, po, tid | 40 | 139 | 14 | 144 | 25 | 144 |
| Hospitalization for Worsened heart failure | Cardiac disorders | Systematic Assessment |
|
| Hospitalization for stroke | Nervous system disorders | Systematic Assessment |
|
| Hospitalization for fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hospitalization for arterial occlusive disease | Vascular disorders | Systematic Assessment |
|
| Infections | Infections and infestations | Non-systematic Assessment |
|
| Worsened renal function | Renal and urinary disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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