Low Dose Ticagrelor Versus Low Dose Prasugrel in Patients With Prior Myocardial Infarction

NCT03387826 | Completed Phase 4

• 1 other identifier: AttikonH14005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Taken together the results from DAPT and PEGASUS-TIMI54, it appears that physicians may consider extending beyond 1 year or reinitiating treatment with a thienopyridine or ticagrelor 60mg bid in patients with a prior MI and features of high ischemic and low bleeding risk. Comparative clinical or pharmacodynamic studies, however, between prasugrel 5 mg od and ticagrelor 60 mg bid in the chronic phase of stable post MI patients have not been performed. In light of this, we believe that a dedicated pharmacodynamic study of ticagrelor 60 bid mg vs prasugrel 5 mg od in a PEGASUS-like population would be informative for the practicing clinician, thus setting the rationale for conducting this specifically designed investigation.

Conditions

Myocardial Infarction; Diabetes Mellitus; Coronary Artery Disease; Renal Disease

Keywords

ticagrelor; prasugrel

Outcome Measures

Primary Outcomes (1)

• Platelet reactivity measured in P2Y12 reaction units (PRU) at the end of the 2 study periods

  Platelet reactivity measured in P2Y12 reaction units (PRU) at the end of the 2 study periods (pre-crossover and post-crossover).

  14 days

Secondary Outcomes (2)

• High platelet reactivity rate at the end of the 2 study periods

  14 days

• VerifyNow P2Y12 assay % inhibition, using the TRAP-induced response at the end of the 2 study periods

  14 days

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Ticagrelor 60mg twice daily followed by Prasugrel 5mg once daily

Drug: Ticagrelor 60 mg; Drug: Prasugrel 5mg

Prasugrel

ACTIVE COMPARATOR

Prasugrel 5m once daily followed by Ticagrelor 60mg twice daily

Drug: Ticagrelor 60 mg; Drug: Prasugrel 5mg

Interventions

Ticagrelor 60 mg DRUG

Ticagrelor 60 mg twice daily

Prasugrel; Ticagrelor

Prasugrel 5mg DRUG

Prasugrel 5 mg once daily

Prasugrel; Ticagrelor

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Post-menopausal female (defined as absence of any vaginal bleeding for a year) or male aged \>50 years
• A spontaneous MI (ST or Non ST segment elevation) 1 to 3 years before enrolment. In addition, at least one of the following high-risk features: age of 65 years or older, diabetes mellitus requiring medication, a second prior spontaneous MI, multivessel coronary artery disease, or non-end stage renal disease (estimated creatinine clearance of \<60 ml per minute).

You may not qualify if:

• Planned use of a P2Y12 receptor antagonist, dipyridamole, cilostazol, or anticoagulant therapy during the study period;
• Known allergy, intolerance, hypersensitivity to ticagrelor or prasugrel or any excipients,
• Active pathological bleeding, severe hepatic impairment, a bleeding disorder or a history of an ischemic stroke or intracranial bleeding, a central nervous system tumor, or an intracranial vascular abnormality;
• Gastrointestinal bleeding within the previous 6 months or major surgery within the previous 30 days;
• Concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole, grapefruit juice over 1 litre daily), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine).
• Increased risk of bradycardic events (e.g. known sick sinus syndrome or third degree AV block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker).
• Inability to adhere to the follow-up requirements or any other reason or condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated.

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

Attikon University Hospital

Chaïdári, 12462, Greece

Location

Related Publications (1)

• Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

  PMID: 35224730 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Diabetes Mellitus; Coronary Artery Disease; Kidney Diseases

Interventions

Ticagrelor; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring

Study Officials

• Dimitrios Alexopoulos, MD

  Attikon Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (outcome assessor)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology, National and Capodestrian University of Athens

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: December 23, 2017
• First Posted: January 2, 2018
• Study Start: January 11, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: March 5, 2019

Record last verified: 2019-03

Locations

GR (1)