Phase 2
Completed N=56
The Effect on Blood Cells, Known as Platelets, Using Prasugrel vs Clopidogrel in Patients With the Heart Problem Acute Coronary Syndrome (ACS)
Source: ClinicalTrials.gov NCT00385944 ↗Enrolled (actual)
56
Serious AEs
3.9%
Results posted
Sep 2010
Primary outcomePrimary: Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) — 27.1; 40.3 Percentage aggregation — p=<0.001
Summary
This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose (LD) of clopidogrel.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) |
27.1; 40.3 | <0.001 sig |
| SECONDARY MPA to 5 μM ADP |
16.9; 25.0 | <0.001 sig |
| SECONDARY Mean Residual Platelet Aggregation (RPA) to 20 µM ADP |
9.4; 21.6 | <0.001 sig |
| SECONDARY Mean Residual Platelet Aggregation (RPA) to 5 µM ADP |
2.7; 7.1 | 0.001 sig |
| SECONDARY Inhibition Platelet Aggregation (IPA) to 20 μM ADP |
64.2; 48.5 | <0.001 sig |
| SECONDARY Inhibition Platelet Aggregation (IPA) to 5 μM ADP |
72.4; 58.8 | 0.001 sig |
| SECONDARY Inhibition of Residual Platelet Aggregation (IRPA) to 20 μM ADP |
87.1; 75.9 | 0.015 sig |
| SECONDARY Inhibition of Residual Platelet Aggregation (IRPA) to 5 μM ADP |
95.6; 91.4 | 0.123 |
| SECONDARY Platelet Reactivity Index (PRI) |
22.1; 39.4 | <0.001 sig |
| SECONDARY P2Y12 Reaction Units (PRU) |
44; 98.7 | <0.001 sig |
| SECONDARY Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD) |
48; 35; 1; 12 | — |
| SECONDARY Change in MPA to 20 μM ADP From Baseline to 6-18 Hrs Post Loading Dose (LD) |
-35.5 | <.001 sig |
| SECONDARY Change in MPA to 20 μM ADP From 6-18 Hrs Post Loading Dose (LD) to 14 Days After the First Maintenance Dose (MD) |
-9; -0.6 | 0.011 sig |
| SECONDARY MPA to 20 μM ADP at 14 Days After the First Maintenance Dose (MD) |
28.9; 38.2 | 0.008 sig |
| SECONDARY MPA to 20 μM ADP at 14 Days After the Second Maintenance Dose (MD) |
42.5; 25 | <0.001 sig |
| SECONDARY Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria |
0; 0; 0; 1; 3; 1 | — |
| SECONDARY Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) |
0; 0; 0; 0; 3; 2 | — |
| SECONDARY Correlation of MPA to 20 μM ADP and PRU |
0.8 | — |
Eligibility Criteria
Inclusion Criteria
- Present with acute coronary syndrome (ACS) and have planned treatment with a one-time 900-mg loading dose of commercially available clopidogrel (administered as a single or cumulative dose).
- Are between the ages of 18 and 85 years.
- Willing and able to sign informed consent.
Exclusion Criteria
- Have overt ST-segment elevation myocardial infarction (STEMI).
- Have cardiogenic shock.
- Have refractory ventricular arrhythmias.
- Have New York Heart Association (NYHA) Class IV congestive heart failure.
- Have severe and uncontrolled hypertension.
- Have active internal bleeding or history of bleeding diathesis.
- Have an increased risk of bleeding.
- Have history of cerebrovascular accidents.
- Have certain abnormal blood level values.
- Are currently receiving chemotherapy or radiation therapy.
Data sourced from ClinicalTrials.gov (NCT00385944). 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. Informational only — not medical advice.