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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016600-23 | Registry Identifier | European Clinical Trials Database (EudraCT) |
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| Name | Class |
|---|---|
| University of Hull | OTHER |
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The investigators are conducting a randomised controlled trial to investigate the clinical and cost effectiveness of Ramipril which is an anti-hypertensive medication in patients with intermittent claudication. The investigators aim to recruit 78 participants in total. The investigators will randomise the 78 participants into two groups: Ramipril group with 39 participants and Placebo group with 39 participants. The investigators will measure Ramipril's effect on walking by doing a simple treadmill test and measuring the maximum walking distance the participant can walk. The investigators also want to examine Ramipril's effect on arterial function, cardiovascular prognosis, quality of life and cost effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramipril | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramipril | Drug | 5 mg/day for 2 weeks then 10 mg/day for 22 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Walking Distance (MWD). | The primary outcome measure for this trial is the Maximum Walking Distance (MWD). Treadmill exercise test will be used to estimate the maximum distance the participant can walk at a speed of 2.5 km/h with a 10 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Other Clinical Indicators of Lower Limb Ischaemia: a) Patient Reported Walking Distance (PRWD) b) Treadmill Intermittent Claudication Distance (ICD) c) Ankle Brachial Pressure Index at Rest (ABPI- r) and Following Treadmill Testing (ABPI - t) | Baseline | |
| Quality of Life: a) Generic - Measured Using the SF36, SF8 and EuroQol (EQ5D) Instruments b) Disease Specific - Measured Using the VascuQol |
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Inclusion Criteria:
Exclusion Criteria:
Documented bilateral renal artery stenosis
Unlikely to be compliant with medication or follow up as determined by the recruiting institution.
Pregnancy
Patients with critical limb ischemia (This includes patients with ischaemic rest pain and ulceration > 2 weeks and/or a resting ankle pressure < 50mmHg- Grades II and III according to Rutherford et al 1997.[56].
Patients who had a recent (less than 3 months) angioplasty or bypass surgery
Patients who are unable to perform a treadmill test due to a limiting heart, respiratory or arthritic disease
History of angioneurotic oedema
Currently taking ACE inhibitor or Angiotensin receptor blocker
Contraindication to ACE inhibitor
History of ACE inhibitor intolerance
A creatinine rise of > 30% from baseline and/or Potassium > 5.9 mmol/l
Unwillingness to participate.
Level 1 evidence for ACE inhibitor treatment, including:
Documented heart failure, left ventricular dysfunction or ejection fraction <35% on previous echocardiography
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| Name | Affiliation | Role |
|---|---|---|
| Ian Chetter, MD, FRCS | University of Hull | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull and East Yorkshire Hospitals | Hull | Yorkshire | HU3 2JZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23842829 | Result | Shahin Y, Cockcroft JR, Chetter IC. Randomized clinical trial of angiotensin-converting enzyme inhibitor, ramipril, in patients with intermittent claudication. Br J Surg. 2013 Aug;100(9):1154-63. doi: 10.1002/bjs.9198. |
| Label | URL |
|---|---|
| Related publications | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramipril | Ramipril: 5 mg/day for 2 weeks then 10 mg/day for 22 weeks |
| FG001 | Placebo | Ramipril: 5 mg/day for 2 weeks then 10 mg/day for 22 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ramipril | Ramipril: 5 mg/day for 2 weeks then 10 mg/day for 22 weeks |
| BG001 | Placebo | Ramipril: 5 mg/day for 2 weeks then 10 mg/day for 22 weeks |
| 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 | Maximum Walking Distance (MWD). | The primary outcome measure for this trial is the Maximum Walking Distance (MWD). Treadmill exercise test will be used to estimate the maximum distance the participant can walk at a speed of 2.5 km/h with a 10 | Posted | Median | Inter-Quartile Range | Metres | Baseline |
|
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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 | Ramipril | Ramipril: 5 mg/day for 2 weeks then 10 mg/day for 22 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Long | Hull University Teaching Hospitals NHS Trust | 01482 311918 | judith.long3@nhs.net |
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| ID | Term |
|---|---|
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017257 | Ramipril |
| ID | Term |
|---|---|
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 0,2,6,24 weeks |
| Cardiovascular Prognosis Using: a) Framingham, PROCAM, QRISK and Manchester Charts Scoring Systems b) B-type Natriuretic Peptide (BNP) and N- Terminal Prohormone BNP (NT-proBNP) and a Lipid Profile ( LDL, HDL, Total Cholesterol, Triglycerides) | 0,2,6,24 weeks |
| Markers of Endothelial Function and Ischaemia Reperfusion a) IL6 b) Soluble Intercellular Adhesion Molecule-1 (sICAM -1) c) sE Selectin d) Urine Albumin Creatinine Ratio ( UACR) | 0,2,6,24 weeks |
| Arterial Effects: a) Arterial Stiffness by Measuring the Pulse Wave Velocity and Assessing the Effects on the Extracellular Matrix by Measuring Metalloproteinases (MMPs) and Tissue Inhibitor Metalloproteinases (TIMPs). b) Flow Mediated Vasodilatation | 0,2,6,24 weeks |
| Health Economics (Cost Effectiveness / Utility) | 24 weeks |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Other Clinical Indicators of Lower Limb Ischaemia: a) Patient Reported Walking Distance (PRWD) b) Treadmill Intermittent Claudication Distance (ICD) c) Ankle Brachial Pressure Index at Rest (ABPI- r) and Following Treadmill Testing (ABPI - t) | Not Posted | Baseline | Participants |
| Secondary | Quality of Life: a) Generic - Measured Using the SF36, SF8 and EuroQol (EQ5D) Instruments b) Disease Specific - Measured Using the VascuQol | Not Posted | 0,2,6,24 weeks | Participants |
| Secondary | Cardiovascular Prognosis Using: a) Framingham, PROCAM, QRISK and Manchester Charts Scoring Systems b) B-type Natriuretic Peptide (BNP) and N- Terminal Prohormone BNP (NT-proBNP) and a Lipid Profile ( LDL, HDL, Total Cholesterol, Triglycerides) | Not Posted | 0,2,6,24 weeks | Participants |
| Secondary | Markers of Endothelial Function and Ischaemia Reperfusion a) IL6 b) Soluble Intercellular Adhesion Molecule-1 (sICAM -1) c) sE Selectin d) Urine Albumin Creatinine Ratio ( UACR) | Not Posted | 0,2,6,24 weeks | Participants |
| Secondary | Arterial Effects: a) Arterial Stiffness by Measuring the Pulse Wave Velocity and Assessing the Effects on the Extracellular Matrix by Measuring Metalloproteinases (MMPs) and Tissue Inhibitor Metalloproteinases (TIMPs). b) Flow Mediated Vasodilatation | Not Posted | 0,2,6,24 weeks | Participants |
| Secondary | Health Economics (Cost Effectiveness / Utility) | Not Posted | 24 weeks | Participants |
| 0 |
| 14 |
| 6 |
| 14 |
| EG001 | Placebo | Ramipril: 5 mg/day for 2 weeks then 10 mg/day for 22 weeks | 0 | 19 | 0 | 19 |
| Dizziness | General disorders | Non-systematic Assessment |
|
| Hyperkalaemia | Endocrine disorders | Non-systematic Assessment |
|
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |