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To demonstrate that patients treated with cangrelor can be directly switched to oral prasugrel and that patients treated with prasugrel can be switched to cangrelor without a significant decrease in the extent of inhibition of platelet aggregation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Day 1 - Cangrelor + Prasugrel (60mg) post infusion | Experimental | Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation |
|
| Day 8 - Prasugrel (10mg) Dosing (5 doses) | Experimental | Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h) |
|
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Experimental | Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time. |
|
| Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h | Experimental | Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time. |
|
| Day 8 - Prasugrel (10mg) Dosing (6 doses) | Experimental | Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cangrelor | Drug | Cangrelor IV administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence or absence of the study drugs was examined for each of the endpoints using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response). | Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures. |
| Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone | A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 μM adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response). | Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence of absence of the study drugs was examined for each of the endpoints as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay. |
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Inclusion Criteria:
greater than / equal to 18 and less than 75 years of age
stable coronary artery disease defined by the following criteria
Previous myocardial infarction defined by admission to the hospital with elevation of markers of injury or the presence of pathologic Q waves on at least 2 contiguous electrocardiogram (ECG) leads.
OR
Previous revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG).
AND
Treatment with aspirin (ASA) 81 mg daily.
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| Name | Affiliation | Role |
|---|---|---|
| David J. Schneider | University of Vermont Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fletcher Allen Health Care | Burlington | Vermont | 05401 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion | Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion. Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8. |
| FG001 | Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h | Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time. cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion. Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8. |
| FG002 | Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time. cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion. Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8. |
| FG003 | Day 8 - Prasugrel (10mg) Dosing (5 Doses) | Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h) cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion. Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8. |
| FG004 | Day 8 - Prasugrel (10mg) Dosing (6 Doses) | Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h) cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion. Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1 |
| |||||||||||||
| Day 8 |
|
Intent-to-treat (ITT) population
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| ID | Title | Description |
|---|---|---|
| BG000 | Day 8 - Prasugrel (10mg) Dosing (6 Doses) | Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h) Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion. Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence or absence of the study drugs was examined for each of the endpoints using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response). | Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data. | Posted | Mean | Standard Deviation | % aggregation | Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures. |
|
Screening through Follow-up Period
Follow-up period:
Each subject was contacted by telephone 5 to 7 days after Study Day 8 to assess adverse event (AEs) / serious adverse events (SAEs) and to ensure that any previously identified AEs/SAEs had resolved.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Day 1 - Prasugrel (60mg) at 1.5 Hrs | Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.5 hours after infusion start). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jayne Prats, PhD - VP, Global Knowledge Management | The Medicines Company | 888-779-MDCO | 1510 | jayne.prats@themedco.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C117446 | cangrelor |
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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| Prasugrel | Drug | Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion. Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8. |
|
| Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures. |
| Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone | A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay. | Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion |
| Bleeding Events in Accordance With the GUSTO Scale | Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Days 1 and 8. Reports of bleeding were to be evaluated by performance of a CBC. Bleeding was to be reported as recommended and quantified in accordance with the GUSTO criteria [The GUSTO Investigators, 1993]. | Day 1 through Day 8 |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Day 8 - Prasugrel (10mg) Dosing (5 Doses) | Prasugrel discontinued 48h prior to initiation of cangrelor infusion (2h) Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion. Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Cangrelor IV + Oral prasugrel (60mg) were administered within 5 minutes after cangrelor IV discontinuation cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion. Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8. |
| OG001 | Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time. cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion. Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8. |
| OG002 | Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h | Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time. cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion. Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8. |
|
|
| Primary | Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone | A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 μM adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response). | Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data. | Posted | Mean | Standard Deviation | % aggregation | Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion |
|
|
|
| Secondary | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence of absence of the study drugs was examined for each of the endpoints as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay. | Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data. | Posted | Mean | Standard Deviation | platelet reaction units (PRU) | Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures. |
|
|
|
| Secondary | Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone | A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay. | Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data. | Posted | Mean | Standard Deviation | platelet reaction units (PRU) | Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion |
|
|
|
| Secondary | Bleeding Events in Accordance With the GUSTO Scale | Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Days 1 and 8. Reports of bleeding were to be evaluated by performance of a CBC. Bleeding was to be reported as recommended and quantified in accordance with the GUSTO criteria [The GUSTO Investigators, 1993]. | Posted | Number | participants | Day 1 through Day 8 |
|
|
|
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Day 1 - Prasugrel (60mg) at 1.0 hr | Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.0 hour after infusion start). | 0 | 3 | 0 | 3 |
| EG002 | Day 1 - Prasugrel (60mg) - Post Infusion (2.0 hr) | Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 Prasugrel: Day 1: Subjects received prasugrel (60 mg) post infusion, [at 2.0 hrs, (within 5 minutes of discontinuing the cangrelor infusion)]. | 0 | 3 | 0 | 3 |
| EG003 | Day 8 - Prasugrel (10mg) Dosing (6 Doses) | Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h) Subjects were given 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8. Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 | 0 | 6 | 0 | 6 |
| EG004 | Day 8 - Prasugrel (10mg) Dosing (5 Doses) | Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h) Subjects were given 5 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8. Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 | 0 | 6 | 0 | 6 |
| Infusion site hemmorrhage | General disorders | General disorders and administrations site conditions |
|
Prior to submission for publication or presentation, the Institution will provide the Sponsor thirty (30) days for review and comment, If necessary, Sponsor will be given an additional sixty (60) days to allow Sponsor to file a patent application or taking such other measures as Sponsor deems appropriate to establish and preserve its proprietary rights upon the manuscript or other material for such publication. Sponsor may remove confidential or proprietary information.
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
|
| 2.5h - PRU |
|
| 2.75h - PRU |
|
| 3.0h - PRU |
|
| 4.0h - PRU |
|
| Life-threatening/Severe |
|