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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| Cumberland Pharmaceuticals | INDUSTRY |
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This study evaluates whether addition of the thromboxane receptor antagonist to chronic aspirin therapy improves endothelial function and reduces non-platelet thromboxane generation in patients with established cardiovascular disease. Half of participants will receive ifetroban and the other half will receive matching placebo for the 4 week study period.
Thromboxane is a prostaglandin produced in healthy individuals mainly in platelets, where it mediates platelet activation and vasoconstriction via binding to cellular thromboxane-prostanoid (TP) receptors. The cardioprotective effect of aspirin is due to suppression of platelet thromboxane generation and reactivity. Unfortunately 25-50% of patients with cardiovascular disease taking ASA continue to generate thromboxane from non-platelet sources, which significantly increases their risk of atherothrombosis and death. Evidence suggests that oxidative stress is a potent stimulus for thromboxane generation in endothelial cells that involves autocrine/paracrine signaling through the TP receptor. This clinical trial addresses the central hypothesis that vascular endothelial cells under oxidative stress are a major source of non-platelet thromboxane generation in patients with cardiovascular disease and that antagonism of the TP receptor will suppress its formation and improve endothelial function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ifetroban | Active Comparator | Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks. |
|
| Placebo | Placebo Comparator | Matching placebo administered once daily for a minimum of 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ifetroban Sodium | Drug | Ifetroban sodium 250 mg capsule once daily for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Reactive Hyperemia Index (RHI) | The change in Reactive Hyperemia Peripheral Index (RHI) as measured by Arterial Tonometry. The Reactive Hyperemia Index (RHI) is calculated as the ratio of post- to pre-occlusion peripheral arterial tone signals on the occluded side, normalized to the control side, and further adjusted for baseline vascular tone. RHI is automatically measured by the EndoPAT 2000 software. According to the manufacturer, an RHI value greater than 1.67 is considered normal, while a lower value indicates endothelial dysfunction and is associated with an increased risk of cardiovascular events. | Baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent Flow-mediated Vasodilation (FMD) | The measure is the change in flow-mediated vasodilation (FMD) as measured by Brachial vasoractivity | Baseline to 4 weeks |
| Change in Urinary TXB2-M |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey J Rade, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ifetroban | Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks. Ifetroban Sodium: Ifetroban sodium 250 mg capsule once daily for 4 weeks |
| FG001 | Placebo | Matching placebo administered once daily for a minimum of 4 weeks. Placebo: Placebo arm to match Ifetroban Sodium once daily for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ifetroban | Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks. Ifetroban Sodium: Ifetroban sodium 250 mg capsule once daily for 4 weeks |
| 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 | Change in Reactive Hyperemia Index (RHI) | The change in Reactive Hyperemia Peripheral Index (RHI) as measured by Arterial Tonometry. The Reactive Hyperemia Index (RHI) is calculated as the ratio of post- to pre-occlusion peripheral arterial tone signals on the occluded side, normalized to the control side, and further adjusted for baseline vascular tone. RHI is automatically measured by the EndoPAT 2000 software. According to the manufacturer, an RHI value greater than 1.67 is considered normal, while a lower value indicates endothelial dysfunction and is associated with an increased risk of cardiovascular events. | 5 participants were withdrawn from the placebo group | Posted | Median | Inter-Quartile Range | percentage index change | Baseline to 4 weeks |
|
6 weeks
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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 | Ifetroban | Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks. Ifetroban Sodium: Ifetroban sodium 250 mg capsule once daily for 4 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey J Rade MD | University of Massachusetts Medical School | 774-441-6310 | jeffrey.rade@umassmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2022 | Sep 13, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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Single center, prospectively randomized, double-blinded, placebo-controlled clinical trial.
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| Placebo |
| Drug |
Placebo arm to match Ifetroban Sodium once daily for 4 weeks. |
|
Urinary urinary TXB2-M measured by 11-dhTXB2 ELISA
| Baseline to 4 weeks |
| Adverse Event |
|
| Physician Decision |
|
Matching placebo administered once daily for a minimum of 4 weeks.
Placebo: Placebo arm to match Ifetroban Sodium once daily for 4 weeks.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Matching placebo administered once daily for a minimum of 4 weeks. Placebo: Placebo arm to match Ifetroban Sodium once daily for 4 weeks. |
|
|
| Secondary | Change in Percent Flow-mediated Vasodilation (FMD) | The measure is the change in flow-mediated vasodilation (FMD) as measured by Brachial vasoractivity | 5 participants from the placebo group were withdrawn from the study | Posted | Median | Inter-Quartile Range | percentage | Baseline to 4 weeks |
|
|
|
| Secondary | Change in Urinary TXB2-M | Urinary urinary TXB2-M measured by 11-dhTXB2 ELISA | Posted | Median | Inter-Quartile Range | pg/mg creatinine | Baseline to 4 weeks |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 18 |
| 29 |
| EG001 | Placebo | Matching placebo administered once daily for a minimum of 4 weeks. Placebo: Placebo arm to match Ifetroban Sodium once daily for 4 weeks. | 1 | 28 | 3 | 28 | 17 | 28 |
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Cholecistitis | Hepatobiliary disorders | Systematic Assessment |
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| Celulitis on the left foot and ankle | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Wound complication (edema, erythema, pain) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Diabetic skin ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cardiac chest pain | Cardiac disorders | Systematic Assessment |
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| Myocardial infaction | Cardiac disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| AST increased | Investigations | Systematic Assessment |
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| Bone Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Epistaxis | Ear and labyrinth disorders | Systematic Assessment |
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| Nasal congestion | Ear and labyrinth disorders | Systematic Assessment |
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| Non-cardiac chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pharyngitis | Ear and labyrinth disorders | Systematic Assessment |
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| Urinary urgency | Renal and urinary disorders | Systematic Assessment |
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| ALT increased | Investigations | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Insomnia | Nervous system disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Maculopapular rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Situational syncope | Nervous system disorders | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Alcohol Intolerance Syndrome | Metabolism and nutrition disorders | Systematic Assessment |
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| Anemia | General disorders | Systematic Assessment |
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| Depression | Nervous system disorders | Systematic Assessment |
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| Cognitive disturbance | Nervous system disorders | Systematic Assessment |
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| Leucocytosis | Immune system disorders | Systematic Assessment |
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| Lymphocytopenia | Immune system disorders | Systematic Assessment |
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| Neutrophilia | Infections and infestations | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Anxiety | Nervous system disorders | Systematic Assessment |
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| Creatinine increased | Investigations | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Surgical and medical procedure | Surgical and medical procedures | Systematic Assessment |
|
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