Trial · NCT01107899
Study to Learn When Platelets Return to Normal After One Loading Dose of Anti-platelet Drugs in Patients With Symptoms of Acute Coronary Syndromes
NCT01107899, Phase 1, Terminated, Eli Lilly and Company; results first posted 2012-01-12
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ConductScience Library. Study to Learn When Platelets Return to Normal After One Loading Dose of Anti-platelet Drugs in Patients With Symptoms of Acute Coronary Syndromes. Trials, record NCT01107899. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01107899
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Learn When Platelets Return to Normal After One Loading Dose of Anti-platelet Drugs in Patients With Symptoms of Acute Coronary Syndromes
- NCT number
- NCT01107899
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 29 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Acute Coronary Syndromes
- Interventions
- clopidogrel, prasugrel
- First posted
- 2010-04-21
- Last updated
- 2012-03-09
- Results first posted
- 2012-01-12
- Limitations and caveats
- Trial was terminated early due to enrollment futility which resulted in limited data and the inability to analyze some outcome measures.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Returning to Baseline Platelet Function | Days 3, 5, 7, 9, and 11 | Participants were classified as having platelet function return to baseline after loading dose (LD) on the first day that P2Y12 Reaction Units (PRU) was no more than 60 PRU below baseline and remained in this range. PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of adenosine diphosphate (ADP)-stimulated platelet aggregation. |
| Secondary | The Day on Which 50%, 75% and 90% of Subjects Return to Baseline Platelet Function Following a Single LD of 30-mg or 60-mg Prasugrel or 600-mg Clopidogrel | Up through 11 days | This outcome measure was not analyzed due to the limited sample size. |
| Secondary | The Day When the Proportion of Participants Who Return to Baseline Platelet Function in the 30-mg and 60-mg Prasugrel Groups is Similar to the 600-mg Clopidogrel Group at Day 5 and Day 7 | Up through 11 days | The day at which the proportion of participants who return to baseline platelet P2Y12 receptor function in the prasugrel 30 mg and 60 mg LD groups is similar (within 10% absolute difference) to the proportion of subjects who return to baseline platelet P2Y12 receptor function at day 5 and day 7 in the clopidogrel 600 mg LD group, obtained from Kaplan Meier curves for the primary washout population, was to be presented. This outcome measure was not analyzed due to the limited sample size. |
| Secondary | Number of Days to the Return of Baseline Platelet Function Following One Loading Dose (LD) | Up through 11 days | The return of baseline platelet function following one LD of prasugrel (30 mg or 60 mg) or 600 mg LD of clopidogrel assessed by Verify Now™ P2Y12 Reaction Units (VN-PRU). This outcome measure was not analyzed because it was not appropriate to estimate the days based on the non-inferiority approach due to the limited sample size. |
| Secondary | Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU | Up through 11 days | To show effect of initial inhibition of platelet aggregation as measured by Accumetrics Verify Now™ P2Y12 on the day to return to baseline platelet function, a regression model was fitted with day to return as outcome variable and initial inhibition as fixed effect. Results are reported as the predicted day to return to baseline platelet function by derived VN-PRU percent (%) inhibition at 24 hours post LD. The derived VN-PRU % inhibition is calculated as a percent decrease of PRU from baseline using the following formula: (\[PRU at baseline - PRU at 24 hours post LD\]/PRU at baseline) x 100%. |
| Secondary | Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hrs Post-LD) by VN-PRU | Up through 11 days | PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of adenosine diphosphate (ADP)-stimulated platelet aggregation. This outcome measure was not analyzed due to the limited sample size. |
| Secondary | Platelet Function 24 Hours Post Loading Dose | 24 hours post-loading dose | PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of ADP-stimulated platelet aggregation. |
| Secondary | Percentage of Poor Pharmacodynamic Responders by Platelet Aggregation at 24 Hours Post-LD | 24 hours post-loading dose | Platelet aggregation was assessed by Accumetrics Verify Now™ P2Y12, and poor responders were those with PRU greater than or equal to 230. |
| Secondary | Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA) | Up through 11 days | Initial inhibition of platelet aggregation was measured by LTA at 5 and 20 μM ADP. Maximum platelet aggregation (MPA) is reported by day. |
| Secondary | Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS) | Up through 11 days | Return of baseline platelet function was assessed by Multiplate® ADP test and ADP test High Sensitivity (HS). Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. The agonist ADP was added to stirred whole blood after dilution (1:2 with 0.9% NaCl solution) in a final concentration of 6.4 µM (ADP Test) or in final concentration of 6.4 µM ADP plus 9.4 nM Prostaglandin E1 (PGE1) (ADPtest HS). Platelet aggregation was continuously recorded for 5 minutes and quantified as area under the aggregation curve (AUC=AU\*min) of aggregation units (AU). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Returning to Baseline Platelet Function | Days 3, 5, 7, 9, and 11 | Primary Washout Population: Included participants who completed the study, had evaluable pharmacodynamic (PD) data through Day 11. Participants with a missed visit were not included in the Primary Washout Population. | percentage of participants | NUMBER |
| SECONDARY | The Day on Which 50%, 75% and 90% of Subjects Return to Baseline Platelet Function Following a Single LD of 30-mg or 60-mg Prasugrel or 600-mg Clopidogrel | Up through 11 days | Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis. | days | NUMBER |
| SECONDARY | The Day When the Proportion of Participants Who Return to Baseline Platelet Function in the 30-mg and 60-mg Prasugrel Groups is Similar to the 600-mg Clopidogrel Group at Day 5 and Day 7 | Up through 11 days | Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis. | day | NUMBER |
| SECONDARY | Number of Days to the Return of Baseline Platelet Function Following One Loading Dose (LD) | Up through 11 days | Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis. | days | MEAN |
| SECONDARY | Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU | Up through 11 days | ITT Washout Population: All randomized participants who received study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD. One participant discontinued on Day 3 without returning to baseline and is not included in analysis. | days | NUMBER |
| SECONDARY | Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hrs Post-LD) by VN-PRU | Up through 11 days | Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis. | days | MEAN |
| SECONDARY | Platelet Function 24 Hours Post Loading Dose | 24 hours post-loading dose | LD ITT population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD. | P2Y12 Reaction Units (PRU) | MEAN |
| SECONDARY | Percentage of Poor Pharmacodynamic Responders by Platelet Aggregation at 24 Hours Post-LD | 24 hours post-loading dose | LD ITT Population: All randomized participants who received an LD with evaluable PD measurements. | percentage of participants | NUMBER |
| SECONDARY | Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA) | Up through 11 days | ITT Washout Population: All randomized participants who received the study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD. | percent platelet aggregation | MEAN |
| SECONDARY | Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS) | Up through 11 days | ITT Washout Population: All randomized participants who received the study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD. | Aggregation Units * minutes | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group121
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Returning to Baseline Platelet Function | Clopidogrel 600 mg | Day 3 | 60.0 | percentage of participants | |
| Percentage of Participants Returning to Baseline Platelet Function | Prasugrel 60 mg | Day 3 | 0 | percentage of participants | |
| Percentage of Participants Returning to Baseline Platelet Function | Prasugrel 30 mg | Day 3 | 0 | percentage of participants | |
| Percentage of Participants Returning to Baseline Platelet Function | Clopidogrel 600 mg | Day 5 | 80.0 | percentage of participants | |
| Percentage of Participants Returning to Baseline Platelet Function | Prasugrel 60 mg | Day 5 | 10.0 | percentage of participants | |
| Percentage of Participants Returning to Baseline Platelet Function | Prasugrel 30 mg | Day 5 | 0 | percentage of participants | |
| Percentage of Participants Returning to Baseline Platelet Function | Clopidogrel 600 mg | Day 7 | 100.0 | percentage of participants | |
| Percentage of Participants Returning to Baseline Platelet Function | Prasugrel 60 mg | Day 7 | 60.0 | percentage of participants | |
| Percentage of Participants Returning to Baseline Platelet Function | Prasugrel 30 mg | Day 7 | 100.0 | percentage of participants | |
| Percentage of Participants Returning to Baseline Platelet Function | Clopidogrel 600 mg | Day 9 | 100.0 | percentage of participants |
1 to 10 of 121Source ClinicalTrials.gov
See all 121 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clopidogrel 600 mg | 10 | |
| Overall Study | STARTED | Prasugrel 60 mg | 10 | |
| Overall Study | STARTED | Prasugrel 30 mg | 9 | |
| Overall Study | Received at Least One Dose of Study Drug | Clopidogrel 600 mg | 10 | |
| Overall Study | Received at Least One Dose of Study Drug | Prasugrel 60 mg | 10 | |
| Overall Study | Received at Least One Dose of Study Drug | Prasugrel 30 mg | 8 | |
| Overall Study | Loading Dose (LD) Intent to Treat (ITT) | Clopidogrel 600 mg | 5 | |
| Overall Study | Loading Dose (LD) Intent to Treat (ITT) | Prasugrel 60 mg | 10 | |
| Overall Study | Loading Dose (LD) Intent to Treat (ITT) | Prasugrel 30 mg | 6 | |
| Overall Study | ITT Washout Population | Clopidogrel 600 mg | 5 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Clopidogrel 600 mg | 0 | 10 | 0 |
| serious | Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Prasugrel 60 mg | 0 | 10 | 0 |
| serious | Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Prasugrel 30 mg | 1 | 8 | 1 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clopidogrel 600 mg | ||
| Total, all-cause mortality | Prasugrel 60 mg | ||
| Total, all-cause mortality | Prasugrel 30 mg | ||
| Total, other adverse events | Clopidogrel 600 mg | 0 | 10 |
| Total, other adverse events | Prasugrel 60 mg | 0 | 10 |
| Total, other adverse events | Prasugrel 30 mg | 0 | 8 |
| Total, serious adverse events | Clopidogrel 600 mg | 0 | 10 |
| Total, serious adverse events | Prasugrel 60 mg | 0 | 10 |
| Total, serious adverse events | Prasugrel 30 mg | 1 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22372531 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01107899
GET https://conductscience.org/api/trials/v1/NCT01107899/results?page=2