Is smooth muscle mitogenesis down regulated by platelet inactivation with combination antiplatelet therapy after angioplasty for claudication? - CAVA2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-005174-23-GB

Enrollment

Registered

2005-03-11

Start date

2005-04-11

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent claudication = stenosis of superficial femoral artery requiring percutaneous angioplasty

Interventions

Trade Name: Plavix (Clopidogrel) Product Name: Plavix (Clopidogrel) Pharmaceutical Form: Tablet INN or Proposed INN: Clopidogrel CAS Num

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Unable to consent - Hb 3x upper limit normal - Creatinine > 2x upper limit normal - BMI > 33 - Age 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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: 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.; 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	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: 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.; 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

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026