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Pilot study of a dose-adjusted regimen of tiroban during percutnaeous coronary intervention

Pilot study of a dose-adjusted regimen of tiroban during percutnaeous coronary intervention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005446-39-GB
Enrollment
200
Registered
2006-02-20
Start date
2006-04-27
Completion date
Unknown
Last updated
2012-04-03

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

Conditions

Percutaneous coronary intervention for coronary artery stenosis

Interventions

Trade Name: Aggrastat Product Name: Aggrastat Product Code: Aggrastat Pharmaceutical Form: Solution for infusion

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Aged 18 years or over Patients with acute coronary syndromes scheduled for urgent or emergency coronary angiography Patients scheduled for high-risk elective PCI Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Increased risk of bleeding sufficient to contra-indicate the use of GPIIb/IIIa antagonists, according to British National Formulary guidance for the use of these drugs: Active internal bleeding; majory surgery, intracranial or intraspinal surgery or trauma within the last 2 month; stroke within the last 2 years; intracranial neoplasm, arteriovenous malformation or aneurysm; severe uncontrolled hypertension; haemorrhagic diasthesis, thrombocytopenia or INR > 2.0; vasculitis; hypertensive or untreated proliferative diabetic retinopathy. Currently receiving abciximab or eptifibatide (increased risk of bleeding due to interaction). Creatinine > 300 umol/L (risk of drug accumulation) Breast feeding (risk of toxicity, listed as contraindication in the BNF)

Design outcomes

Primary

MeasureTime frame
Main Objective: To study the safety and feasibility of dose-adjusted tirofiban in patients undergoing percutaneous coronary intervention using a whole blood microaggregation assay;Secondary Objective: ;Primary end point(s): Not specified - see protocol

Countries

United Kingdom

Outcome results

None listed

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