What side effects are associated with this type of intervention?

Common treatments for Peripheral Arterial Disease (PAD) include ACE inhibitors like Ramipril, cilostazol, and pentoxifylline. ACE inhibitors can cause side effects such as cough, elevated blood potassium levels, low blood pressure, dizziness, and renal impairment. Cilostazol may lead to headaches, diarrhea, palpitations, and dizziness. Pentoxifylline can cause gastrointestinal disturbances, dizziness, and headaches. These medications aim to improve walking performance and reduce claudication symptoms but require monitoring for potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Peripheral Arterial Disease (PAD), including medications like cilostazol and pentoxifylline, which improve walking distance and reduce symptoms of claudication. While specific FDA approvals for ACE inhibitors like Ramipril in the context of PAD are not detailed, Ramipril has shown promise in clinical trials by improving walking performance through mechanisms such as reducing oxidative damage, TGF-β1 production, and collagen deposition in muscle tissues. Other treatments for PAD include supervised exercise therapy and surgical revascularization.

What other types of research exist?

Promising novel alternatives to Ramipril for PAD patients include: <ol> <li>PCSK9 Inhibitors (e.g., Evolocumab, Alirocumab): These have shown significant reductions in cardiovascular events and major adverse limb events in PAD patients.</li> <li>GLP-1 Receptor Agonists (e.g., Liraglutide, Semaglutide): These agents have demonstrated cardiovascular benefits and reduced amputation risks in PAD patients with diabetes.</li> <li>SGLT2 Inhibitors (e.g., Dapagliflozin): While primarily used for diabetes, these have shown potential benefits in reducing cardiovascular events in PAD patients.</li> <li>Vorapaxar: A PAR-1 antagonist that has shown efficacy in reducing acute limb ischemia events in PAD patients.</li> <li>Dual Antiplatelet Therapy (e.g., Ticagrelor with Aspirin): This combination has shown a reduction in major adverse limb events in PAD patients with diabetes.</li> </ol>

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ACE Inhibitor

Ramipril for Intermittent Claudication

Phase 4

Recruiting

Led By Iraklis I Pipinos, MD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests if Ramipril can help patients with PAD who have severe leg pain walk better. Ramipril may improve muscle function by reducing damage and stiffness in the legs.

Who is the study for?

This trial is for individuals with Peripheral Artery Disease (PAD) who experience leg pain during walking due to claudication. They should have stable blood pressure, cholesterol, and diabetes management. Participants must not have severe kidney issues, a history of angioedema with ACE inhibitors, critical limb ischemia, or other conditions severely affecting their walking ability.

What is being tested?

The study tests if Ramipril can improve walking performance and quality of life in PAD patients by reducing muscle damage and fibrosis compared to standard treatments like cilostazol and pentoxifylline. It's hypothesized that Ramipril may help by decreasing oxidative damage in muscles.

What are the potential side effects?

Ramipril may cause side effects such as coughing, high potassium levels which can affect the heart rhythm, low blood pressure especially after the first dose, dizziness due to low blood pressure, headaches or tiredness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absolute Claudication Distance

Secondary study objectives

6-minute Walking Distance

Average Daily Steps Taken

Capillary density.

+20 more

Side effects data

From 2009 Phase 4 trial • 252 Patients • NCT00391846

Cardiac Failure

Myocardial Infarction

Anaemia

Chronic Obstructive Pulmonary Disease

Syncope

Ventricular Tachycardia

Angina Pectoris

Artial Fibrillation

Dyspnoea

Hyperkalaemia

Pneumonia

Aortic Stenosis

Cerebral Infarction

Cerebrovascular Accident

Concussion

Confusional State

Diverticulitis

Duodenal Ulcer Haemorrhage

Dyspepsia

Endocarditis

Hepatic Failure

Intestinal Ischaemia

Multi-Organ Failure

Polymyalgia Rheumatica

Right Ventricular Failure

Spinal Fracture

Back Pain

Bladder Neoplasm

Blood Electrolytes Abnormal

Bradycardia

Muscular Weakness

Osteoarthritis

Angina Unstable

B-Cell Lymphoma

Bleeding Varicose Vein

Bronchitis

Carotid Artery Stenosis

Intervertebral Disc Compression

Pulmonary Odema

Respiratory Tract Infection Viral

Septic Shock

Peripheral Ischaemia

100%

80%

60%

40%

20%

Study treatment Arm

Guided by NT-proBNP

Not Guided by NT-proBNP

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ramipril TreatmentExperimental Treatment1 Intervention

6 months treatment with the medication Ramipril

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ramipril

FDA approved

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peripheral Arterial Disease (PAD) is primarily managed through medications, exercise therapy, and surgical interventions. The most common pharmacological treatments include cilostazol, pentoxifylline, and ACE inhibitors like ramipril. Cilostazol works by inhibiting phosphodiesterase III, leading to vasodilation and reduced platelet aggregation, which improves blood flow. Pentoxifylline improves blood flow by decreasing blood viscosity. Ramipril, an ACE inhibitor, improves walking performance and quality of life by reducing oxidative damage, TGF-β1 production, and collagen deposition in the affected muscles. These mechanisms are crucial as they address the underlying pathophysiology of PAD, improving symptoms and potentially slowing disease progression.

Effect of chronic treatment with the vasopeptidase inhibitor AVE 7688 and ramipril on endothelial function in atherogenic diet rabbits.Microcirculation in hyperglycemic patients with IDDM without diabetic complications--effect of low-dose angiotensin-converting enzyme inhibition.