Aspirin Resistance Reversibility in Diabetic Patients (ARRDM)

Azienda Ospedaliera San Giovanni Battista

Status and phase: Unknown; Phase 4

Conditions: Aspirin Resistance

Treatments: Drug: lysine acetylsalicylate

Study type: Interventional

Funder types: Other

Identifiers

NCT01935193

ASAR160

Details and patient eligibility

About

The aim of the study is assessing the prevalence of aspirin resistance in a cohort of diabetic patients. Those found resistant has been undergone pharmacological tests using different drug formulations to investigate the reversibility of aspirin resistance.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diabete mellitus type 2
• asa since 30 days at least
• plts >150000 and <450000

Exclusion criteria

• recent ACS (within 30 days)
• anticoagulant therapy
• haemorragic diathesis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

160 participants in 1 patient group

asa resistant

Experimental group

Description:

asa resistant patients receive endovenous infusion of lysine acetylsalicylate 288 mg and if asa resistance has been reversed they have been prescribed oral soluble salt of lysine acetylsalicylate.

Treatment:

Drug: lysine acetylsalicylate