Coronary Artery DiseasePhase 2NCT01852019

Cangrelor Prasugrel Transition Study

A Phase 2 study testing Cangrelor and Prasugrel in people with Coronary Artery Disease, run by The Medicines Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Coronary Artery Disease
What is being tested?: Cangrelor and Prasugrel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Jun 2013to Jul 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Fletcher Allen Health Care
Burlington, Vermont, 05401

Other trials in United States

About this study

Official title: A Study of the Transition From IV Cangrelor to Oral Prasugrel, and Prasugrel to Cangrelor, in Patients With Coronary Artery Disease.

Conditions: Coronary Artery Disease
Being tested: Cangrelor, Prasugrel
Keywords: CAD
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CangrelorDrug
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
PrasugrelDrug
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.

Study groups in NCT01852019
Study group	Role	What they receive
Day 1 - Cangrelor + Prasugrel (60mg) post infusion	Experimental	Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation Receives: Drug: Cangrelor; Drug: Prasugrel
Day 8 - Prasugrel (10mg) Dosing (5 doses)	Experimental	Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h) Receives: Drug: Cangrelor; Drug: Prasugrel
Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h	Experimental	Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time. Receives: Drug: Cangrelor; Drug: Prasugrel
Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h	Experimental	Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time. Receives: Drug: Cangrelor; Drug: Prasugrel
Day 8 - Prasugrel (10mg) Dosing (6 doses)	Experimental	Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h) Receives: Drug: Cangrelor; Drug: Prasugrel

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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].
Measured: Day 1 through Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Jul 2013

First posted13 May 2013 (estimated)
Study startJun 2013
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01852019
Sponsor's protocol ID: MDCO-CAN-13-01
Status last verified: May 2015
First submitted: 6 May 2013
Last updated: 24 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of the Transition From IV Cangrelor to Oral Prasugrel, and Prasugrel to Cangrelor, in Patients With Coronary Artery Disease.
ClinicalTrials.gov ID: NCT01852019
Acronym / sponsor ID: MDCO-CAN-13-01
Conditions: Coronary Artery Disease
Keywords: CAD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: The Medicines CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 13 May 2013 (estimated)
Results: Posted 28 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Day 1 - Cangrelor + Prasugrel (60mg) post infusion	Experimental	Drug: Cangrelor, Drug: PrasugrelCangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation
Day 8 - Prasugrel (10mg) Dosing (5 doses)	Experimental	Drug: Cangrelor, Drug: PrasugrelPrasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h)
Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h	Experimental	Drug: Cangrelor, Drug: PrasugrelCangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time.
Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h	Experimental	Drug: Cangrelor, Drug: PrasugrelCangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time.
Day 8 - Prasugrel (10mg) Dosing (6 doses)	Experimental	Drug: Cangrelor, Drug: PrasugrelPrasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

greater than / equal to 18 and less than 75 years of age
stable coronary artery disease defined by the following criteria
OR
AND

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CangrelorCangrelor IV administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8	Drug	Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h, Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h, Day 1 - Cangrelor + Prasugrel (60mg) post infusion, Day 8 - Prasugrel (10mg) Dosing (5 doses), Day 8 - Prasugrel (10mg) Dosing (6 doses)
PrasugrelDay 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.	Drug	Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h, Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h, Day 1 - Cangrelor + Prasugrel (60mg) post infusion, Day 8 - Prasugrel (10mg) Dosing (5 doses), Day 8 - Prasugrel (10mg) Dosing (6 doses)

Primary outcome

Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
Time frame: Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.
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).
Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone
Time frame: Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion
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).

3 secondary outcomes

Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
Time frame: 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
Time frame: Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion
Bleeding Events in Accordance With the GUSTO Scale
Time frame: Day 1 through Day 8

Results and safety

Results posted to the registry on 28 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion	3	3
Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h	3	3
Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h	6	6
Day 8 - Prasugrel (10mg) Dosing (5 Doses)	0	0
Day 8 - Prasugrel (10mg) Dosing (6 Doses)	0	0

Primary outcome: Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)

Time frame: Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.. Mean (Standard Deviation). Unit: % aggregation

Measure	Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) n = 3	Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h n = 6	Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h n = 3
Prasugrel Reference (6.0h or 5.5 h)	1.0 (1.0)	2.8 (3.1)	5.0 (6.2)
2.25 h	27 (20)	25 (15)	45 (24)
2.5 h	56 (6.7)	42 (27)	62 (3.8)
2.75 h	64 (2.1)	31 (33)	69 (4.6)
3.0 h	58 (14)	24 (26)	51 (5.1)
4.0 h	1.0 (1.7)	10 (15)	15 (18)

Population analysed: Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.

Primary outcome: Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone

Time frame: Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion. Mean (Standard Deviation). Unit: % aggregation

Measure	Day 8 - Prasugrel (10mg) Dosing (6 Doses) n = 6	Day 8 - Prasugrel (10mg) Dosing (5 Doses) n = 6
1.0 h	0.5 (0.8)	1.3 (2.0)
2.0 h	0.0 (0.0)	1.0 (1.4)

Population analysed: Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening through Follow-up Period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Day 1 - Prasugrel (60mg) at 1.5 Hrs	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Day 1 - Prasugrel (60mg) at 1.0 hr	0 of 3 (0%)	0 of 3 (0%)	Not reported
Day 1 - Prasugrel (60mg) - Post Infusion (2.0 hr)	0 of 3 (0%)	0 of 3 (0%)	Not reported
Day 8 - Prasugrel (10mg) Dosing (6 Doses)	0 of 6 (0%)	0 of 6 (0%)	Not reported
Day 8 - Prasugrel (10mg) Dosing (5 Doses)	0 of 6 (0%)	0 of 6 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David J. Schneider principal investigator

University of Vermont Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cangrelor and Prasugrel in people with Coronary Artery Disease, run by The Medicines Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) (time frame: Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01852019.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.