Phase 2 N=50 Clopidogrel Pharmacogenomics Project
Disease Susceptibility
Primary: Clopidogrel Resistance, Defined by P2Y12 Reaction Units (PRU)Value >230 — 30; 18 Number of Patients with PRU>230 — p==0.02
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=47 A Pharmacokinetic Study on the Effect of LY2216684 on the Active Metabolite of Clopidogrel
Major Depressive Disorder
Primary: Pharmacokinetics of R-130964, Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) — 61.8; 55.3 hours*nanograms/milliliters (h*ng/mL)
Phase 4 N=61 Impact of Chronic Kidney Disease on Clopidogrel Effects in Diabetes Mellitus
Chronic Kidney Disease (CKD) · Type 2 Diabetes Mellitus (T2DM) · Coronary Artery Disease (CAD)
Primary: Platelet Reactivity Index (PRI) Assessed by VASP. The Cutoff for High Platelet Reactivity is >50% — 67.5; 67.2 PRI%
N/A N=35 Downstream Molecular Signals of P2Y12 Receptors in Hyporeactive Patients Under Clopidogrel Treatment A Possible Mechanism of HOTPR(High On-Treatment Platelet Reactivity)
Stable Angina
Primary: PRU(Platelet Rreactivity Unit) 24 Hours After DAPT(Dual AntiPlatelet Therapy) Western Blot After Medication — 148; 289; 79; 132 PRU(Platelet Rreactivity Unit)
Phase 4 N=302 Clopidogrel and Aspirin Interaction Study-2
Drug Action Increased
Primary: Blood Concentration of the Active Metabolite of Clopidogrel — 14.45; 13.80 ng/ml — p=0.66
N/A N=18 Clopidogrel Pharmacogenetics (PGX) Bench to Bedside
Metabolism of Clopidogrel
Primary: Change in Platelet Aggregation Following Therapy With Clopidogrel — 62.9; 68.1; 62.5; 63.2 percentage of aggregation
Phase 2 N=333 Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56
Myocardial Infarction · Percutaneous Coronary Intervention
Primary: Comparisons of Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation Platelet Reactivity Index (PRI) — 71.0; 57.5; 62.4; 46.9 % of PRI
Phase 1 N=20 PPI and Clopidogrel Response
Drug Interaction
Primary: Platelet Function as Assessed by the P2Y12 Reactivity Index — 56.1; 61.6; 56; 61 Percentage of platelet reactivity index
Phase 4 N=80 Switching From Ticagrelor to Clopidogrel in Patients With Coronary Artery Disease
Coronary Artery Disease
Primary: Platelet Reactivity Unit — 177; 164; 174; 26 PRU — p=>0.05
Phase 1 N=32 Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products
Pharmacodynamics
Primary: Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State) — 1853.58; 1892.84 percent…
Phase 4 N=5,276 Tailored Antiplatelet Therapy Following PCI
Coronary Artery Disease · Acute Coronary Syndrome · Stenosis
Primary: Occurrence of the a Major Adverse Cardiovascular Event in Subjects Identified as CPY2C19 LOF Carriers by TaqMan. — 35; 54 Participants
Phase 4 N=110 The Influence of Smoking Status on Prasugrel and Clopidogrel Treated Subjects Taking Aspirin and Having Stable Coronary Artery Disease
Coronary Artery Disease
Primary: Inhibition of Platelet Aggregation (IPA) in Prasugrel-treated and Clopidogrel-treated Smokers and Non-smokers Following 9 Days of Maintenance Therapy. — 70.3; 65.6…
Phase 4 N=100 CES1 Crossover Trial of Clopidogrel and Ticagrelor
Myocardial Infarction · Thrombosis · Platelet Dysfunction
Primary: Change in Maximal Platelet Aggregation in Response to Clopidogrel — 32.6; 50.8; 35.0 Percent Maximal Platelet Aggregation — p=<0.001
Phase 2 N=15 Cangrelor to Clopidogrel or Prasugrel Transition Study
Coronary Artery Disease (CAD)
Primary: Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or…
Phase 1 N=84 Clopidogrel Bioequivalence Study in Healthy Subjects
Bioequivalence, AUC, Cmax, Pharmacokinetics
Primary: Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf)) — 1.05; 0.992; 1.09 ng*h/mL
Phase 4 N=77 Pharmacodynamic and Pharmacokinetic of Switching From Cangrelor to Prasugrel in ACS Patients Undergoing PCI
Coronary Artery Disease · Acute Coronary Syndrome
Primary: Platelet Reactivity Measured by VerifyNow — 23; 153; 65 PRU
Phase 4 N=14 Prasugrel Versus Ticagrelor in Patients With CYP2C19 Loss-of-function: a Validation Study
Coronary Artery Disease
Primary: P2Y12 Reaction Unit (PRU) — 5; 24 PRU — p=<0.05
Phase 4 N=56 Prasugrel/Clopidogrel Maintenance Dose Washout Study
Coronary Artery Disease
Primary: The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition…
Phase 4 N=52 Pharmacological Effects of Crushing Prasugrel in STEMI Patients
Coronary Artery Disease
Primary: P2Y12 Reaction Units (PRU) — 95; 164 PRU — p=0.022
Phase 2 N=282 Clopidogrel to Prasugrel in Acute Coronary Syndrome (ACS) Patients
Acute Coronary Syndrome
Primary: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation 6 Hours After Prasugrel Loading Dose (LD) — 57.86; 35.61; 53.92 PRU — p=0.188
Phase 1 N=72 Comparison of Prasugrel and Clopidogrel in Low Body Weight Versus Higher Body Weight With Coronary Artery Disease
Coronary Artery Disease
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…
Phase 4 N=81 Tailoring P2Y12 Inhibiting Therapy in Patients Requiring Oral Anticoagulation After PCI
Coronary Artery Disease
Primary: Platelet Reactivity Measured as PRU — 154.5; 23; 104 PRU
Phase 4 N=65 A Pharmacodynamic Study Comparing Prasugrel Versus Ticagrelor in Patients Undergoing PCI With CYP2C19 Loss-of-function:
Coronary Artery Disease
Primary: Platelet Reactivity — 36; 33 PRU
Phase 4 N=20 PD and PK Profiles of Switching Between Cangrelor and Ticagrelor Following Ticagrelor Pre-treatment
Coronary Artery Disease
Primary: Platelet Reactivity Measured by VerifyNow — 16.9; 12.6 P2Y12 reaction units
Phase 1 N=155 Comparison of Prasugrel and Clopidogrel in Very Elderly and Non-Elderly Patients With Stable Coronary Artery Disease
Coronary Artery Disease
Primary: Change in Maximum Platelet Aggregation (MPA) to 20 Micromoles (μM) Adenosine Diphosphate (ADP) as Measured by Light Transmission Aggregometry (LTA) From Baseline to 12…
Phase 4 N=6 CES1 Carriers in the PAPI Study
Heart Diseases · Coronary Disease · Coronary Artery Disease
Primary: Changes in Platelet Function in Response to Clopidogrel — 37.4; 20.4 percentage of maximum aggregation change
Phase 1 N=6 Metabolism and Pharmacokinetics of [14C]-BI 409306 After Administration as Oral Solution in Healthy Male Volunteers
Healthy
Primary: Mass Balance Recovery of Total Radioactivity in Urine and Faeces: Amount Excreted Within the Time Interval From 0 to the Time of the Last Quantifiable Data Point as a…
N/A N=82 Pharmacodynamic Evaluation of Switching From Prasugrel to Ticagrelor
Coronary Artery Disease · Acute Coronary Syndrome
Primary: Platelet Reactivity Measured as P2Y12 Reaction Units (PRU) Determined by Verify Now-P2Y12 Assay — 45; 63 PRU
Phase 4 N=19 Pharmacogenomics of Antiplatelet Response - I
Platelet Aggregation · Platelet Transcriptome · Coronary Artery Disease
Primary: Difference in ADP-induced Platelet Aggregation — -5.2 Difference in ohms (Post-Pre)
N/A N=283 The Study of CYP2C19 Genotype-Guided Clopidogrel Treatment Models
Coronary Artery Disease · Clopidogrel Resistance · Coronary Thrombosis
Primary: Number of Study Participants Who Died From Any Cause (Death From Any Cause) — 8; 2; 7 Participants