Cangrelor to Clopidogrel or Prasugrel Transition Study

NCT ID: NCT01979445

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-02
• Study Completion Date: 2014-01-20

Brief 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. 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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Prasugrel 30 Min After Cangrelor

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).

Group Type: EXPERIMENTAL

Cangrelor

Intervention Type: DRUG

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.

Prasugrel

Intervention Type: DRUG

Prasugrel 60 mg single oral dose

Clopidogrel Within 5 Min After Cangrelor

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).

Group Type: EXPERIMENTAL

Cangrelor

Intervention Type: DRUG

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.

Clopidogrel

Intervention Type: DRUG

Clopidogrel 600 mg single oral dose

Clopidogrel 1.5 Hrs During Cangrelor

Clopidogrel 600 mg administered orally 1.5 hrs after the initiation of cangrelor infusion on Day 1.

Group Type: EXPERIMENTAL

Cangrelor

Intervention Type: DRUG

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.

Clopidogrel

Intervention Type: DRUG

Clopidogrel 600 mg single oral dose

Clopidogrel 1 Hr During Cangrelor

Clopidogrel 600 mg administered orally 1 hr after the initiation of cangrelor infusion on Day 1.

Group Type: EXPERIMENTAL

Cangrelor

Intervention Type: DRUG

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.

Clopidogrel

Intervention Type: DRUG

Clopidogrel 600 mg single oral dose

Interventions

Cangrelor

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.

Intervention Type: DRUG

Clopidogrel

Clopidogrel 600 mg single oral dose

Intervention Type: DRUG

Prasugrel

Prasugrel 60 mg single oral dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Greater than or equal to 18 and less than 75 years of age, of either sex, and of any race.

2. Stable CAD defined by the following criteria:

1. 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

2. Previous revascularization by percutaneous coronary intervention or coronary artery bypass graft, and

3. Treatment with aspirin 81 mg daily.

Exclusion Criteria

1. Known intolerance or contraindication to cangrelor or prasugrel, or any ingredients of the respective formulation.

2. Any antiplatelet (other than aspirin) or anticoagulant medication within the previous 30 days.

3. Acute coronary syndrome within the previous 12 months.

4. 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.

5. Anemia (for example, hematocrit less than 35%).

6. Prior stroke (any type), prior cerebral arteriovenous malformation or intracranial aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery).

7. Known or suspected pregnancy, or lactating females.

8. Known severe renal insufficiency (glomerular filtration rate less than 30 milliliter [mL]/min).

9. Inability to provide informed consent.

10. Moderate or severe hepatic impairment as per Investigator's discretion (elevation of liver function tests).

11. Inability to swallow oral medication at time of randomization.

12. 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.

13. 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).

14. 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.

15. 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.

16. 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.

17. Active pathological bleeding, or a history of transient ischemic attack.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Medicines Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J. Schneider, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont Medical Center

Locations

Fletcher Allen Health Care

Burlington, Vermont, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 26381736 (View on PubMed)

Other Identifiers

MDCO-CAN-13-02

Identifier Type: -

Identifier Source: org_study_id