Rapid Activity of Platelet Inhibitor Drugs Study 2

NCT01805570 | Completed Phase 4 DMC

• 1 other identifier: RAPID STUDY 2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the RAPID study is to evaluate the superiority rapid onset of action of Ticagrelor 360 mg LD versus Prasugrel 60 mg LD, in 50 patients with STEMI (ST segment elevation myocardial infarction) undergoing PPCI with bivalirudin monotherapy. Secondary study aim is to found out clinical predictors of high residual platelet reactivity in the first hour after a novel oral antiplatelet agent LD.

Conditions

Myocardial Infarction

Keywords

platelet inhibitor; ST-segment Elevation; Myocardial Infarction; stent; prasugrel; ticagrelor

Outcome Measures

Primary Outcomes (1)

• Residual Platelet Reactivity by VerifyNow

  residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after oral antiplatelet agent LD.

  1 hour

Secondary Outcomes (1)

• High residual platelet reactivity

  2,4,12 hours

Study Arms (2)

Prasugrel loading dose

ACTIVE COMPARATOR

25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Prasugrel before PPCI.

Drug: Prasugrel

Ticagrelor loading dose

ACTIVE COMPARATOR

25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Ticagrelor before PPCI.

Drug: Ticagrelor

Interventions

Prasugrel DRUG

25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Prasugrel before PPCI. The loading dose of Prasugrel will be 60 mg. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered .

Prasugrel loading dose

Ticagrelor DRUG

25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Ticagrelor before PPCI. The loading dose of Ticagrelor will be 360 mg. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered .

Ticagrelor loading dose

Eligibility Criteria

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

You may qualify if:

• Patients presenting within 12 hours from the onset of symptoms with STEMI (ST segment elevation myocardial infarction)
• Informed, written consent

You may not qualify if:

• Age \< 18 years or Age \> 75 years
• Active bleeding; bleeding diathesis; coagulopathy
• Increased risk of bradycardiac events
• History of gastrointestinal or genitourinary bleeding \<2 months
• Major surgery in the last 6 weeks
• History of intracranial bleeding or structural abnormalities
• Suspected aortic dissection
• Any previous TIA (transient ischemic attack)/stroke
• Any other condition that may put the patient at risk or influence study results or investigator's opinion (severe haemodynamic instability, known malignancies or other comorbid conditions with life expectancy \<1 year)
• Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux .
• Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows
• Known relevant hematological deviations: Hb \<10 g/dl, Platelet count \<100x10\^9/l
• Use of coumadin derivatives within the last 7 days
• Chronic therapy with prasugrel or ticagrelor
• Known severe liver disease, severe renal failure

Sponsors & Collaborators

• David Antoniucci: lead
• A.R. CARD Onlus Foundation: collaborator

Study Sites (1)

Careggi Hospital

Florence, Italy

Location

Related Publications (1)

• Parodi G, Bellandi B, Valenti R, Migliorini A, Marcucci R, Carrabba N, Giurlani L, Gensini GF, Abbate R, Antoniucci D. Comparison of double (360 mg) ticagrelor loading dose with standard (60 mg) prasugrel loading dose in ST-elevation myocardial infarction patients: the Rapid Activity of Platelet Inhibitor Drugs (RAPID) primary PCI 2 study. Am Heart J. 2014 Jun;167(6):909-14. doi: 10.1016/j.ahj.2014.03.011. Epub 2014 Apr 4.

  PMID: 24890542 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Prasugrel Hydrochloride; Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

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

Study Officials

• David Antoniucci, MD

  Careggi Hospital, Division of Invasive Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head Division of Invasive Cardiology

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 6, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

IT (1)