Coronary Artery Disease (CAD)Phase 2BRIDGENCT01979445

Cangrelor to Clopidogrel or Prasugrel Transition Study

A Phase 2 study testing Cangrelor, Clopidogrel and Prasugrel in people with Coronary Artery Disease (CAD), 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

There are two separate objectives in this study: 1. To demonstrate the pharmacodynamic (PD) profile when participants treated with cangrelor are switched to oral prasugrel 60 mg administered 30 minutes (min) after cangrelor infusion is discontinued 2. Read more about this study

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Coronary Artery Disease (CAD)
What is being tested?: Cangrelor, Clopidogrel 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: 15 participants
Where: 1 siteUnited States
Study dates: 2 Dec 2013to 20 Jan 2014
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 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Greater than or equal to 18 and less than 75 years of age, of either sex, and of any race.
Stable CAD 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 or coronary artery bypass graft, and
Treatment with aspirin 81 mg daily.

Who cannot join

Known intolerance or contraindication to cangrelor or prasugrel, or any ingredients of the respective formulation.
Any antiplatelet (other than aspirin) or anticoagulant medication within the previous 30 days.
Acute coronary syndrome within the previous 12 months.
History of bleeding diathesis or known coagulopathy such as; impaired hemostasis; known international normalized ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders, such as, von Willebrand's disease or hemophilia), acquired bleeding disorders, and unexplained clinically significant bleeding disorders; thrombocytopenia (platelet count less than 100,000/microliter [µL]), or history of thrombocytopenia or neutropenia associated with clopidogrel.
Anemia (for example, hematocrit less than 35%).
Prior stroke (any type), prior cerebral arteriovenous malformation or intracranial aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery).

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Known or suspected pregnancy, or lactating females.
Known severe renal insufficiency (glomerular filtration rate less than 30 milliliter [mL]/min).
Inability to provide informed consent.
Moderate or severe hepatic impairment as per Investigator's discretion (elevation of liver function tests).
Inability to swallow oral medication at time of randomization.
Any clinically significant disease or condition affecting a major organ system, including but not limited to gastrointestinal, renal, hepatic, endocrinologic, broncho-pulmonary, neurological, or metabolic disease.
Any surgical or medical condition which, in the judgment of the Investigator, might interfere with the pharmacokinetics, distribution, metabolism, or excretion of the study drug (if applicable).
Treatment with other investigational medicinal products or devices within 30 days or 5 half-lives, whichever is longer, prior to the administration of the drug, or planned use of investigational medicinal products or devices.
Participants who, for any reason, are deemed by the Investigator to be inappropriate for this study, including participants who are unable to communicate or to cooperate with the Investigator.
Participant is the Investigator or his/her deputy, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
Active pathological bleeding, or a history of transient ischemic attack.

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 Cangrelor to Clopidogrel or Prasugrel in Patients With Coronary Artery Disease.

There are two separate objectives in this study:

To demonstrate the pharmacodynamic (PD) profile when participants treated with cangrelor are switched to oral prasugrel 60 mg administered 30 minutes (min) after cangrelor infusion is discontinued
To demonstrate the PD profile when participants treated with cangrelor are switched to oral clopidogrel 600 mg administered during or immediately after cangrelor infusion.

Conditions: Coronary Artery Disease (CAD)
Being tested: Cangrelor, Clopidogrel, 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 intravenously (IV) administered as a 30 microgram (µg)/kilogram (kg) bolus, followed by 4 µg/kg/min infusion for 2 hrs on Day 1.
ClopidogrelDrug
Clopidogrel 600 mg single oral dose
PrasugrelDrug
Prasugrel 60 mg single oral dose

Study groups in NCT01979445
Study group	Role	What they receive
Prasugrel 30 Min After Cangrelor	Experimental	Prasugrel 60 milligram (mg) administered orally 30 min after the discontinuation of cangrelor infusion on Day 1 (2.5 hours [hrs] after initiation of cangrelor infusion). Receives: Drug: Cangrelor; Drug: Prasugrel
Clopidogrel Within 5 Min After Cangrelor	Experimental	Clopidogrel 600 mg administered orally within 5 min after the discontinuation of the cangrelor infusion on Day 1 (2 hrs after initiation of cangrelor infusion). Receives: Drug: Cangrelor; Drug: Clopidogrel
Clopidogrel 1.5 Hrs During Cangrelor	Experimental	Clopidogrel 600 mg administered orally 1.5 hrs after the initiation of cangrelor infusion on Day 1. Receives: Drug: Cangrelor; Drug: Clopidogrel
Clopidogrel 1 Hr During Cangrelor	Experimental	Clopidogrel 600 mg administered orally 1 hr after the initiation of cangrelor infusion on Day 1. Receives: Drug: Cangrelor; Drug: Clopidogrel

What is being measured

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

Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone
A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using light transmittance aggregometry (LTA). LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (sec) (final/terminal aggregation response).
Measured: Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion
Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor Alone
A reference point for cangrelor was chosen for comparison and designated as the administration time of prasugrel 60 mg or clopidogrel 600 mg (2.5, 2, 1.5, or 1 hrs). Platelet function was assessed using LTA. LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was examined using LTA and expressed as % aggregation in response to 20 μM ADP at 300 sec (final/terminal aggregation response).
Measured: Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion

Secondary outcomes (3)

Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay
A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was assessed by platelet reaction units (PRU), determined by the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay is designed to directly measure the effects of drugs on the P2Y12 receptor, using prostaglandin E1 in addition to ADP to increase intraplatelet cyclic adenosine monophosphate (cAMP). Platelet reactivity was expressed in PRU.
Measured: Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion
Extent of Preservation of Platelet Inhibitory Effect of Cangrelor Treatment After Prasugrel or Clopidogrel Compared to Treatment With Cangrelor Alone Determined By VerifyNow P2Y12 Assay
A reference point for cangrelor was chosen for comparison and designated as the administration time of prasugrel 60 mg or clopidogrel 600 mg (2.5, 2, 1.5, or 1 hrs). Platelet function was assessed using the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was assessed by PRU, determined by the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay is designed to directly measure the effects of drugs on the P2Y12 receptor, using prostaglandin E1 in addition to ADP to increase intraplatelet cAMP. Platelet reactivity was expressed in PRU.
Measured: Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion
Bleeding Events In Accordance With GUSTO Scale
Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Day 1. Reports of bleeding were to be evaluated by performance of a CBC. Participants were assessed for bleeding events in accordance with the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) scale.
The severity of bleeding events by GUSTO Criteria is defined as the following:
- Severe/life-threatening: fatal, intracranial hemorrhage, or if hemodynamic compromise results
- Moderate: transfusion required
- Mild: no transfusion or hemodynamic compromise
A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Screening through the follow-up period (5 to 7 days after Day 1)

Timeline

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

2 Dec 201320 Jan 2014

First posted8 Nov 2013 (estimated)
Study start2 Dec 2013
Primary completion20 Jan 2014
Study completion20 Jan 2014

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronary Artery Disease (CAD)Studies 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
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01979445
Sponsor's protocol ID: MDCO-CAN-13-02
Acronym: BRIDGE
Status last verified: Feb 2020
First submitted: 1 Nov 2013
Last updated: 26 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Schneider DJ, Agarwal Z, Seecheran N, Gogo P. Pharmacodynamic Effects When Clopidogrel is Given Before Cangrelor Discontinuation. J Interv Cardiol. 2015 Oct;28(5):415-9. doi: 10.1111/joic.12229. Epub 2015 Sep 18.
PubMed 26381736

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 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of the Transition From Cangrelor to Clopidogrel or Prasugrel in Patients With Coronary Artery Disease.
ClinicalTrials.gov ID: NCT01979445
Acronym / sponsor ID: BRIDGE / MDCO-CAN-13-02
Conditions: Coronary Artery Disease (CAD)
Keywords: CAD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: The Medicines CompanyIndustry (pharma, biotech, devices)
Study start: 2 Dec 2013 (actual)
Primary completion: 20 Jan 2014 (actual)
Study completion: 20 Jan 2014 (actual)
First posted: 8 Nov 2013 (estimated)
Results: Posted 5 Mar 2018

Clinical summary

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

There are two separate objectives in this study:

To demonstrate the pharmacodynamic (PD) profile when participants treated with cangrelor are switched to oral prasugrel 60 mg administered 30 minutes (min) after cangrelor infusion is discontinued
To demonstrate the PD profile when participants treated with cangrelor are switched to oral clopidogrel 600 mg administered during or immediately after cangrelor infusion.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Prasugrel 30 Min After Cangrelor	Experimental	Drug: Cangrelor, Drug: PrasugrelPrasugrel 60 milligram (mg) administered orally 30 min after the discontinuation of cangrelor infusion on Day 1 (2.5 hours [hrs] after initiation of cangrelor infusion).
Clopidogrel Within 5 Min After Cangrelor	Experimental	Drug: Cangrelor, Drug: ClopidogrelClopidogrel 600 mg administered orally within 5 min after the discontinuation of the cangrelor infusion on Day 1 (2 hrs after initiation of cangrelor infusion).
Clopidogrel 1.5 Hrs During Cangrelor	Experimental	Drug: Cangrelor, Drug: ClopidogrelClopidogrel 600 mg administered orally 1.5 hrs after the initiation of cangrelor infusion on Day 1.
Clopidogrel 1 Hr During Cangrelor	Experimental	Drug: Cangrelor, Drug: ClopidogrelClopidogrel 600 mg administered orally 1 hr after the initiation of cangrelor infusion on Day 1.

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Greater than or equal to 18 and less than 75 years of age, of either sex, and of any race.
Stable CAD defined by the following criteria:
or

Key exclusion criteria (17 listed)

Known intolerance or contraindication to cangrelor or prasugrel, or any ingredients of the respective formulation.
Any antiplatelet (other than aspirin) or anticoagulant medication within the previous 30 days.
Acute coronary syndrome within the previous 12 months.
History of bleeding diathesis or known coagulopathy such as; impaired hemostasis; known international normalized ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders, such as, von Willebrand's disease or hemophilia), acquired bleeding disorders, and unexplained clinically significant bleeding disorders; thrombocytopenia (platelet count less than 100,000/microliter [µL]), or history of thrombocytopenia or neutropenia associated with clopidogrel.
Anemia (for example, hematocrit less than 35%).

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 intravenously (IV) administered as a 30 microgram (µg)/kilogram (kg) bolus, followed by 4 µg/kg/min infusion for 2 hrs on Day 1.	Drug	Clopidogrel 1 Hr During Cangrelor, Clopidogrel 1.5 Hrs During Cangrelor, Clopidogrel Within 5 Min After Cangrelor, Prasugrel 30 Min After Cangrelor
ClopidogrelClopidogrel 600 mg single oral dose	Drug	Clopidogrel 1 Hr During Cangrelor, Clopidogrel 1.5 Hrs During Cangrelor, Clopidogrel Within 5 Min After Cangrelor
PrasugrelPrasugrel 60 mg single oral dose	Drug	Prasugrel 30 Min After Cangrelor

Primary outcome

Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone
Time frame: Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion
A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using light transmittance aggregometry (LTA). LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (sec) (final/terminal aggregation response).
Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor Alone
Time frame: Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion
A reference point for cangrelor was chosen for comparison and designated as the administration time of prasugrel 60 mg or clopidogrel 600 mg (2.5, 2, 1.5, or 1 hrs). Platelet function was assessed using LTA. LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was examined using LTA and expressed as % aggregation in response to 20 μM ADP at 300 sec (final/terminal aggregation response).

3 secondary outcomes

Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay
Time frame: Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion
Extent of Preservation of Platelet Inhibitory Effect of Cangrelor Treatment After Prasugrel or Clopidogrel Compared to Treatment With Cangrelor Alone Determined By VerifyNow P2Y12 Assay
Time frame: Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion
Bleeding Events In Accordance With GUSTO Scale
Time frame: Screening through the follow-up period (5 to 7 days after Day 1)

Results and safety

Results posted to the registry on 5 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prasugrel 30 Min After Cangrelor	3	3
Clopidogrel Within 5 Min After Cangrelor	3	3
Clopidogrel 1.5 Hrs During Cangrelor	6	6
Clopidogrel 1 Hr During Cangrelor	3	3

Primary outcome: Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone

Time frame: Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion. Mean (Standard Deviation). Unit: % aggregation

Measure	Prasugrel 30 Min After Cangrelor n = 3	Clopidogrel Within 5 Min After Cangrelor n = 3	Clopidogrel 1.5 Hrs During Cangrelor n = 6	Clopidogrel 1 Hr During Cangrelor n = 3
Prasugrel/Clopidogrel Reference (6 or 5.5 hrs)	1.3 (1.5)	21.7 (16.4)	50.0 (16.8)	50.3 (15.9)
2.25 hrs	16.3 (10.1)	26.0 (7.9)	22.2 (16.0)	33.3 (7.5)
2.5 hrs	60.0 (7.5)	49.7 (7.1)	54.3 (11.7)	62.0 (3.6)
2.75 hrs	63.3 (1.5)	58.3 (7.4)	56.8 (11.3)	67.7 (1.2)
3 hrs	65.0 (2.0)	56.0 (8.9)	56.2 (16.4)	65.0 (9.5)
4 hrs	16.3 (27.4)	38.0 (31.7)	51.2 (27.4)	62.7 (8.5)
5.5 hrs	1.3 (1.5)	26.7 (20.5)	NA (NA)	NA (NA)

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

Primary outcome: Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor Alone

Time frame: Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion. Mean (Standard Deviation). Unit: % aggregation

Measure	Prasugrel 30 Min After Cangrelor n = 3	Clopidogrel Within 5 Min After Cangrelor n = 3	Clopidogrel 1.5 Hrs During Cangrelor n = 6	Clopidogrel 1 Hr During Cangrelor n = 3
Cangrelor Reference (2.5, 2, 1.5, or 1 hrs)	60.0 (7.5)	0 (0)	2.0 (3.5)	3.0 (2.0)
1.75 hrs	0.3 (0.6)	1.0 (1.0)	1.8 (2.5)	1.3 (0.6)
2 hrs	0.3 (0.6)	NA (NA)	1.5 (2.0)	2.3 (1.2)

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening through the follow-up period (5 to 7 days after Day 1). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prasugrel 30 Min After Cangrelor	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Clopidogrel Within 5 Min After Cangrelor	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Clopidogrel 1.5 Hrs During Cangrelor	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Clopidogrel 1 Hr During Cangrelor	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26381736Schneider DJ, Agarwal Z, Seecheran N, Gogo P. Pharmacodynamic Effects When Clopidogrel is Given Before Cangrelor Discontinuation. J Interv Cardiol. 2015 Oct;28(5):415-9. doi: 10.1111/joic.12229. Epub 2015 Sep 18.

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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, MD 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, Clopidogrel and Prasugrel in people with Coronary Artery Disease (CAD), 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 6 inclusion and 17 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 26 Feb 2020. 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 5 Mar 2018). 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 Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone (time frame: Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion). 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 NCT01979445, which also lists 1 linked publication.

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 26 Feb 2020.