E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intermittent claudication = stenosis of superficial femoral artery requiring percutaneous angioplasty |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Can the response of growth factors from platelets (blood cells) and their subsequent effect on smooth muscle cells in the wall of an artery be turned down by inhibiting the activity of blood platelet cells which we have demonstrated to occur from our earlier research after balloon angioplasty?
To evaluate the release of mitogens such as PDGF (in patients on combination antiplatelet therapy) after angioplasty for claudication. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the association between platelet inhibition (in patients on combination antiplatelet therapy) and down-regulation of smooth muscle cell proliferation after angioplasty for claudication. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Full informed consent, no other trial involvement, patient undergoing angioplasty for intermittent claudication. - Hb > 10g/dL - Platelet count > 150x109/L - AAT, AP, GGT all < 3x upper limit normal - Creatinine < 2x upper limit normal - BMI < 33 - Age 18-80 years - No contraindication to clopidogrel or aspirin - No malignancy, coagulopathy or bleeding diathesis - No acute illness within 14 days - No blood transfusion within 14 days - No drug or alcohol abuse - No use of steroids, warfarin or heparin - No peptic ulcer disease - No neutropaenia or thrombocytopaenia
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E.4 | Principal exclusion criteria |
- Unable to consent - Hb < 10g/dL - Platelet count < 150x109/L - AAT, AP, GGT all > 3x upper limit normal - Creatinine > 2x upper limit normal - BMI > 33 - Age <18 or >80 years - Contraindication to clopidogrel or aspirin - Any malignancy, coagulopathy or bleeding diathesis - Acute illness within 14 days - Blood transfusion within 14 days - Drug or alcohol abuse - Use of steroids, warfarin or heparin - Peptic ulcer disease - Neutropaenia or thrombocytopaenia
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E.5 End points |
E.5.1 | Primary end point(s) |
No clinical observations.
Biological measurements:
Of sequential changes in mitogenic factors and adhesional molecules following angioplasty.
Samples of all 50 patients taken at 5 time points: baseline, 1h pre-PTA, 1h post-PTA, 24h post-PTA and 30/7 post-PTA.
Measured levels of; 1) PDGF 2) VEGF 3) VWF 4) Others – E-selectin, ICAM-1
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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When the chronologically last patient has received 30 days of trial drug following angioplasty. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |