Phase 1
N=72
Comparison of Prasugrel and Clopidogrel in Low Body Weight Versus Higher Body Weight With Coronary Artery Disease
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01107925 ↗Enrolled (actual)
72
Serious AEs
0.5%
Results posted
Aug 2012
Primary outcome: Primary: Change From Baseline in Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 (Period 1) — 75.00; 76.40; 47.00; 47.00 percent aggregation — p=0.526
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- prasugrel (Drug); clopidogrel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 (Period 1) |
75.00; 76.40; 47.00; 47.00 | 0.526 |
| SECONDARY Change From Baseline in Vasodilator-Associated Stimulated Phosphoprotein (VASP) at Day 12 of Therapy |
86.57; 86.44; 86.44; 86.77; 86.76; 86.77 | — |
| SECONDARY Change From Baseline in VerifyNow® P2Y12 Reaction Units (PRU) at Day 12 of Therapy |
317.9; 315.3; 315.3; 312.8; 311.0; 312.8 | — |
| SECONDARY Pharmacokinetic (PK) Analysis of the Concentration-Time Curve (AUC) |
28.9; 59.3; 18.4; 19.4; 46.7; 12.7 | — |
| SECONDARY Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) at Day 12 of Therapy |
76.27; 76.20; 76.20; 77.63; 77.93; 77.63 | — |
Summary
The 5-milligram (mg) dose of prasugrel in low body weight (LBW) patients with coronary artery disease produces a pharmacodynamic response within the same therapeutic range as 10-mg dose in higher body weight (HBW) patients.
Eligibility Criteria
Inclusion Criteria
- Subjects with a history of stable coronary artery disease who are not currently indicated for treatment with a thienopyridine (that is, prasugrel, clopidogrel, or ticlopidine)
- Provision of written informed consent
- For women of child-bearing potential only (that is, women who are not surgically or chemically sterilised and who are between menarche and 1 year post menopause), test negative for pregnancy (based on a urine or serum pregnancy test to be performed before randomisation) and agree to use a reliable method of birth control during the study
Exclusion Criteria
- Unstable coronary artery disease
- Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft Surgery (CABG) within the previous 90 days
- History of refractory ventricular arrhythmias within the last 6 months; an implanted defibrillator device; congestive heart failure within 6 months prior to screening; major surgery, or severe trauma, fracture or organ biopsy within 3 months prior to enrollment
- Any planned surgical procedure or any coronary revascularisation (surgical or percutaneous) planned within 60 days following randomisation
- Any known contraindication to treatment with an antiplatelet agent
- Significant hypertension at the time of screening or randomisation
- Clinically significant out-of-range values for platelet count or haemoglobin at screening, in the investigator's opinion, or results of clinical laboratory tests at the time of screening that are judged to be clinically significant for the study population, as determined by the investigator
- Prior history or presence of significant bleeding disorders, abnormal bleeding tendency, or personal history of coagulation or bleeding disorders.
- Prior history or clinical suspicion of cerebral vascular malformations, intracranial neoplasm, Transient Ischemic Attack (TIA) or stroke.
- Prior history of thrombocytopenia or thrombocytosis
- Use of antiplatelet agents (besides aspirin) within 10 days prior to screening; the use (or planned use) of heparin, oral anticoagulants, or fibrinolytic agents within 30 days of screening; or subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDS) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study
Data sourced from ClinicalTrials.gov (NCT01107925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.