Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry

Myocardial Infarction Clinical Trial

— CAMEO  

Official title:

Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04076813
• Other study ID #: Pro00100421
• Status: Recruiting
• Start date: October 16, 2019
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2024
• Source: Chiesi USA, Inc.
• Contact: Leo Brothers
• Phone: 919-668-8322
• Email: joseph.l.brothers[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this registry is to address optimal platelet inhibition during the early management of MI patients prior to coronary angiography or CABG.

Description:

The CAMEO registry is a multicenter observational registry that will collect information on 4,000 patients with NSTEMI or STEMI treated with cangrelor or an oral P2Y12 inhibitor into the registry.

Phase 1: Each site will abstract data from the medical record for the first 50 patients meeting the inclusion and exclusion criteria treated at the hospital within 4 months prior to study initiation or during the study period.

Phase 2: After Phase 1, all cangrelor-treated patients meeting the inclusion and exclusion criteria treated at the hospital no later than 1 month from the discharge date will be entered into the registry, and we will begin sampling non-cangrelor patients in a 2:1 cangrelor: non-cangrelor ratio.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Phase 1 Inclusion Criteria:

For the first 50 patients at each participating site, consecutive patients are entered in the registry if they are = 18 years of age, underwent coronary angiography for a STEMI or NSTEMI, and received cangrelor at any time during the hospitalization or an oral P2Y12 inhibitor during his/her first 48 hours of the hospitalization for MI.

Phase 2 Inclusion Criteria:

Subsequent patients are eligible to be entered in the registry if they are = 18 years of age and underwent coronary angiography for a STEMI or NSTEMI and meet at least 1 of the following criteria:

1. The patient was hospitalized for STEMI and met one of the following inclusion criteria:

• The patient received cangrelor at any time during his/her hospitalization for MI.

• The patient received an oral P2Y12 inhibitor during his/her first 48 hours of hospitalization AND either of the following:

• The patient received a P2Y12 inhibitor and an opiate/opioid within 24 hours prior to or during primary PCI for STEMI presentation.

OR

• The patient underwent coronary angiography followed by CABG during the index MI admission and received any P2Y12 inhibitor within 7 days prior to CABG.

2. The patient was hospitalized for NSTEMI and met one of the following inclusion criteria:

• The patient received cangrelor during his/her hospitalization for MI.

• The patient received an oral P2Y12 inhibitor during his/her first 48 hours of hospitalization AND either of the following:

• The patient underwent coronary angiography followed by CABG during the index MI admission and received any P2Y12 inhibitor within 7 days prior to CABG. OR

• Any 2 of the following criteria without prior PCI or CABG: age> 60 years, male sex, diabetes, EF <40% prior heart failure

Exclusion Criteria: If the patient does not meet the inclusion criteria for either Phase.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United States	The Brigham and Women's Hospital, Inc.	Boston	Massachusetts
United States	Kootenai Hospital District dba Kootenai Health	Coeur d'Alene	Idaho
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	MedStar Health Research Institute, Inc.	Hyattsville	Maryland
United States	The Regents of the University of California on behalf of its San Diego campus	La Jolla	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	The Trustees of Columbia University in the City of New York	New York	New York
United States	Christiana Care Health Services, Inc.	Newark	Delaware
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Chiesi USA, Inc.	Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rymer JA, Bhatt DL, Angiolillo DJ, Diaz M, Garratt KN, Waksman R, Edwards L, Tasissa G, Salahuddin K, El-Sabae H, Dell'Anna C, Davidson-Ray L, Washam JB, Ohman EM, Wang TY. Cangrelor Use Patterns and Transition to Oral P2Y12 Inhibitors Among Patients With — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of Antiplatelet medications used during hospitalization	Antiplatelet use, including switching and discontinuation will be measured by medical record report. The medical record report will include medication start and stop dates and times.	The time frame is hospitalization through discharge, approximately 3 days
Primary	Number of bleeding events during hospitalization as measured by medical record report	Bleeding event entered from the medical record report.	The time frame is hospitalization, up to 7 days post discharge